MindMed Announces Positive Topline Results from Phase 2b Trial of MM-120 in Generalized Anxiety Disorder – Trial met its primary endpoint with MM-120 demonstrating a statistically significant dose-dependent improvement in HAM-A scores four weeks after a single-dose – – MM-120 100 µg demonstrated a clinically and statistically significant HAM-A reduction of 21.3 points, representing a 7.6-point improvement over placebo at Week 4 (p=0.0004, Cohen’s d effect size = 0.88) – – Clinical response rate of 78% in 100 µg and 200 µg dose groups and 50% clinical remission rate in the 100 µg dose group at Week 4 – – MM-120 was generally well-tolerated with mostly mild-to-moderate adverse events that occurred on dosing day – – Company plans to hold an End-of-Phase 2 meeting with the U.S. Food & Drug Administration (FDA) in the first half of 2024 and initiate a Phase 3 clinical program in the second half of 2024 – – Conference call and webcast to take place today at 8:30 am EST – NEW YORK, December 14, 2023 -- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced positive topline results from its Phase 2b clinical trial of MM-120 (lysergide d-tartrate) in generalized anxiety disorder (GAD). The trial met its primary endpoint, with MM-120 demonstrating statistically significant and clinically meaningful dose-dependent improvements on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4. MM-120 was administered as a single dose in a monitored clinical setting with no additional therapeutic intervention. MM-120 100 µg – the dose achieving the highest level of clinical activity – demonstrated a 7.6-point reduction compared to placebo at Week 4 (-21.3 MM-120 vs. -13.7 placebo; p<0.0004; Cohen’s d=0.88). Clinical Global Impressions - Severity (CGI-S) scores on average improved from 4.8 to 2.4 in the 100 ug dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline’ at Week 4 (p<0.001). This clinical activity was observed to be rapid and durable beginning on Day 2 and continuing through Week 4 with no loss of activity observed on either HAM-A or CGI-S. “We are excited by the strong positive results for MM-120 in GAD, particularly given that this is the first study to assess the standalone drug effects of MM-120 in the absence of any psychotherapeutic intervention. These promising findings represent a major step forward in our goal to bring a paradigm-shifting treatment to the millions of patients who are profoundly impacted by GAD,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “We look forward to sharing additional study results in the coming months – including topline 12-week results in the first quarter of 2024 – and working closely with FDA as we finalize the Phase 3 development program for MM-120 in GAD. I would like to thank all of the participants in the study as well as the study investigators and our clinical development team, whose dedication made this important milestone possible.” Daniel Karlin, MD, MA, Chief Medical Officer of MindMed said, “Generalized anxiety disorder is a common condition associated with significant impairment that adversely affects millions of people and there remains a serious unmet need for this patient population. The pharmaceutical industry has largely ignored GAD over recent decades as it has proved extremely difficult to target. Few new treatment options have shown robust activity in GAD since the last new drug approval in 2004, making the strong, rapid, and durable clinical activity of a single dose of MM-120 observed in the trial particularly notable. We believe this study is the first to rigorously assess the efficacy of a drug candidate in this class in the absence of a concurrent therapeutic intervention, which brings hope to the millions of people suffering from GAD and provides additional evidence that MM-120 may play an important role in revolutionizing the treatment of brain health disorders.” Additional secondary and exploratory endpoints included in the primary topline results included HAM-A response and remission rates and Clinical Global Impressions - Severity (CGI-S) scores. Clinical response (50% or greater improvement in HAM-A) at Week 4 was achieved in 78% of participants treated with MM-120 (100 µg or 200 µg) compared to 31% for placebo. Clinical remission (HAM-A ≤ 7) at Week 4 was achieved in 50% of participants treated with MM-120 100 µg. CGI-S scores demonstrated a statistically significant and clinically meaningful improvement compared to placebo in the 100 µg (p≤0.001) and 200 µg (p≤0.01) dose groups. On average, participants receiving MM-120 (100 µg or 200 µg) experienced a 2-unit improvement in the CGI-S score at Week 4, with statistically significant improvements observed as early as one day after treatment and continuing at all evaluated timepoints through Week 4. MM-120 was generally observed to be well tolerated, with mostly transient mild-to-moderate adverse events (AEs) that appear consistent with the pharmacodynamic effects of MM-120. The overall four-week completion rate in the trial was approximately 90% and was 97.5% in the high dose groups, and no participants in the high dose groups discontinued due to an adverse event through Week 4. The most common adverse events (at least 10% incidence in the high dose groups) occurred on dosing day and included illusion, hallucinations, euphoric mood, anxiety, thinking abnormal, headache, paraesthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis and hyperhidrosis. The Company expects that results of this study will support the advancement of MM-120 into Phase 3 clinical development for GAD. The Company plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 and expects to initiate Phase 3 clinical trials in the second half of 2024. The Company expects to present additional topline 12-week data from the study in the first quarter of 2024 and to present full results at a scientific meeting in 2024. Conference Call and Webcast MindMed management will host a conference call at 8:30 AM EST today to discuss the results of MM-120 in GAD. Individuals may participate in the live call via telephone by dialing (877) 407-3982 (domestic) or (201) 493-6780 (international). The webcast can be accessed live here on the News & Events page in the Investors section of the MindMed website, https://mindmed.co/. The webcast will be archived on the Company’s website for at least 30 days after the conference call. About Study MMED008 Study MMED008 is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial enrolled 198 participants who were randomized to receive a single administration of MM-120 at a dose of 25, 50, 100 or 200 µg or placebo. The full analysis set (FAS) for the trial included 194 subjects, those that had at least one valid post-baseline Hamilton Anxiety rating scale (HAM-A) score. Subjects enrolled in the trial presented with severe GAD symptoms (average baseline HAM-A scores of approximately 30). The primary objective of the study was to determine the dose-response relationship of four doses of MM-120 versus placebo as measured by the change in HAM-A from Baseline to Week 4. Secondary objectives, measured up to 12 weeks after the single administration, include assessments of anxiety symptoms, safety and tolerability, as well as other measures of efficacy and quality of life. More information about the trial is available on the MindMed website (mindmed.co) or on clinicaltrials.gov (identifier NCT05407064). About MM-120 Lysergide is a synthetic tryptamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing MM-120 (lysergide D-tartrate), the tartrate salt form of lysergide, for GAD and ADHD. About Generalized Anxiety Disorder GAD is a brain health disorder that results in fear, persistent anxiety and a constant feeling of being overwhelmed. It is characterized by excessive, persistent, and unrealistic worry about everyday things. Approximately 10% of U.S. adults, representing around 20 million people, currently suffer from GAD, an underdiagnosed and underserved indication that is associated with significant impairment, less accomplishment at work and reduced labor force participation. Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2004. About MindMed MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders. MindMed trades on NASDAQ under the symbol MNMD and on the Cboe Canada (formerly known as the NEO Exchange, Inc.) under the symbol MMED. Contacts For Media & Investor Inquiries, please contact: Maxim Jacobs, CFA Vice President, Investor Relations and Corporate Communications Mind Medicine (MindMed) Inc. [email protected] [email protected] https://www.businesswire.com/news/home/20231214537387/en/
MindMed Announces Business Update and Anticipated Milestones for 2024 https://www.businesswire.com/news/h...ss-Update-and-Anticipated-Milestones-for-2024 -- Recently announced statistically significant and clinically meaningful topline Phase 2b data for MM-120 in Generalized Anxiety Disorder (GAD) position for multiple data readouts and catalysts throughout 2024 including initiation of Phase 3 clinical program -- -- Proof-of-Concept study evaluating repeated sub-perceptual dose (20 µg) of lysergide in adults with Attention-Deficit/Hyperactivity Disorder (ADHD) did not meet primary endpoint; no further development activities planned for sub-perceptual dose regimen -- -- Phase 1 Single Ascending Dose Study of MM-402 in Healthy Participants initiated in Q4 2023 -- January 08, 2024 07:45 AM Eastern Standard Time NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today provided a corporate update and outlook for 2024. “Management's Discussion and Analysis of Financial Condition and Results of Operations” Post this “Our strong progress in 2023 culminated in the delivery of statistically and clinically significant topline results for our lead program (MM-120) in our Phase 2b study of GAD. These positive results reinforce our scientific understanding of the mechanism of action for MM-120 and emphasize the critical role we believe the perceptual effects of MM-120 play in driving clinical outcomes,” said Rob Barrow, Chief Executive Officer and Director of MindMed. “We are excited to enter 2024 with an enhanced focus on our lead program. In 2024, we plan to continue working diligently and efficiently to advance our MM-120 program into Phase 3, bringing us one step closer to potentially providing a new treatment option to the millions of patients suffering from GAD. We anticipate several key data milestones for our MM-120 program in 2024, including full 12-week results for MM-120 in GAD, results from our Phase 1 pharmacokinetics bridging study to support advancement of our MM-120 ODT formulation into pivotal clinical trials and additional results from our collaborator University Hospital Basel’s one-year follow-up study of lysergide in anxiety disorders. We will be working closely with the FDA to finalize our Phase 3 development program for MM-120 in GAD and expect to hold our End-of-Phase 2 meeting with FDA in the first half of the year with initiation of our Phase 3 clinical program in the second half of the year.” Business Update MindMed's management team will participate in the BIO Partnering at the J.P. Morgan Healthcare Conference in San Francisco that is being held from January 8-11, 2024. The Company expects to host an analyst and investor day in the first half of 2024, at which the Company plans for its senior management, a physician expert and other leading key opinion leaders to provide an update on the Company’s lead development program MM-120 and discuss the treatment landscape, potential market and commercial opportunity for MM-120 in GAD and other psychiatric disorders. Development Program Updates and Anticipated Milestones MM-120 (lysergide D-tartrate) Generalized Anxiety Disorder (GAD): In December 2023, the Company announced statistically significant and clinically meaningful topline 4-week results from the 198-patient Phase 2b dose-optimization study of MM-120 for the treatment of GAD. MM-120 100 µg – the dose achieving the highest level of clinical activity – demonstrated a 7.6-point reduction on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4 (-21.3 MM-120 vs. -13.7 placebo; p<0.0004; Cohen’s d effect size=0.88), which is more than double the effect sizes seen with the current standards of care1. Clinical response (50% or greater improvement in HAM-A) at Week 4 was achieved in 78% of participants treated with MM-120 (100 µg or 200 µg) compared to 31% for placebo. Clinical remission (HAM-A ≤ 7) at Week 4 was achieved in 50% of participants treated with MM-120 100 µg. The Company plans to share topline 12-week results from the Phase 2b study by the end of the first quarter of 2024, and present full results at a scientific meeting in 2024. The Company intends to share results in the first quarter of 2024 from its pharmacokinetics bridging study of the MM-120 Zydis® orally disintegrating tablet (ODT) formulation, its intended commercial formulation of MM-120 formulation that may enhance intellectual property and market protection with a potentially differentiated biopharmaceutical profile. The Company plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 and expects to initiate its Phase 3 clinical program in the second half of 2024. One-year follow-up data from a Phase 2 placebo-controlled investigator-initiated clinical trial of lysergide in the treatment of anxiety disorders is anticipated in 2024. This study was conducted by the Company’s collaborators at University Hospital Basel (UHB) in Switzerland. Attention-Deficit/Hyperactivity Disorder (ADHD): The Company’s 53-patient Phase 2a proof-of-concept trial in ADHD was designed to assess the safety and efficacy of repeated sub-perceptual dose (20 µg) lysergide administration and did not meet its primary endpoint. In conjunction with the findings from our study of MM-120 in GAD, we believe that these results support the critical role of perceptual effects of MM-120 in mediating a clinical response. The Company intends to continue prioritizing development of its MM-120 program in GAD and other psychiatric indications, using the single perceptual dose (100 µg or greater) regimen that has shown strong positive results in numerous studies. MM-402 (R(-)-MDMA) for Autism Spectrum Disorder (ASD) The Company initiated its first clinical trial of MM-402 (R(-)-MDMA), a single-ascending dose study in adult healthy volunteers in Q4 2023. This Phase 1 study is intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM-402 and will enable further clinical studies to characterize the effects of repeated daily doses of MM402 and the exploration of early signs of efficacy in the ASD population. In October 2023, the Company presented results from a MM-402 nonclinical study in a model of ASD, titled “MM-402 demonstrates better efficacy than S(+)-3,4-MDMA or (±)-3,4-MDMA in Fmr1 knockout mice, an animal model of autism spectrum disorder” at the 36th Annual European College of Neuropsychopharmacology (ECNP) Congress. UHB is currently conducting a Phase 1 investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA in healthy adult volunteers. This trial is designed to assess the tolerability, pharmacokinetics and acute subjective, physiological and endocrine effects of the three molecules. The Company anticipates topline results to be presented in the first half of 2024. About MM-120 Lysergide is a synthetic tryptamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing MM-120 (lysergide D-tartrate), the tartrate salt form of lysergide, for GAD and other psychiatric indications. About MM-402 MM-402 is our proprietary form of R(-)-MDMA (rectus-3,4-methylenedioxymethamphetamine), which we are developing for the treatment of core symptoms of autism spectrum disorder (ASD). MDMA is a synthetic molecule that is often referred to as an empathogen because it is reported to increase feelings of connectedness and compassion. Preclinical studies of R(-)-MDMA demonstrate its acute pro-social and empathogenic effects, while its diminished dopaminergic activity suggest that it has the potential to exhibit less stimulant activity, neurotoxicity, hyperthermia and abuse liability compared to racemic MDMA or the S(+)-enantiomer. About MindMed MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine, and acetylcholine systems. MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.
R-MDMA Patent Application Data https://image-ppubs.uspto.gov/dirsearch-public/print/downloadPdf/20240010628
Lysergic Acid Derivatives With Modified Lsd-like Action https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2023250298&_cid=P21-LQSR22-38874-2 Abstract (EN) A composition of a compound represented generically by FIGURE 1A for use in substance-assisted therapy. A method of changing neurotransmission, by administering a pharmaceutically effective amount of a compound of FIGURE 1A to a mammal, interacting with serotonin 5-HT2A receptors in the mammal, in particular also human beings, and inducing psychoactive effects. A method of treating an individual, by administering a pharmaceutically effective amount of a compound of FIGURE 1A to the individual and treating the individual. (FR) L'invention concerne une composition d'un composé représenté de manière générale par la FIGURE 1A destinée à être utilisée dans une thérapie assistée par psychotrope. L'invention concerne également une méthode de modification de la neurotransmission, par administration d'une dose pharmaceutiquement efficace d'un composé de la FIGURE 1A à un mammifère, qui interagit avec les récepteurs 5-HT2A de la sérotonine chez le mammifère, et en particulier chez les êtres humains, et induit des effets psychoactifs. L'invention concerne en outre une méthode de traitement d'un individu, par administration d'une dose pharmaceutiquement efficace d'un composé de la FIGURE 1A à l'individu, ainsi que le traitement de l'individu. Publication Number WO/2023/250298 Publication Date 28.12.2023 International Application No. PCT/US2023/068668 International Filing Date 19.06.2023 IPC A61K 31/48 2006.1 C07D 457/06 2006.1 Applicants MIND MEDICINE, INC. [US]/[US] Inventors TRACHSEL, Daniel LIECHTI, Matthias Emanuel LUSTENBERGER, Felix Agents KOHN, Kenneth I. Priority Data 63/353,673 20.06.2022 US Publication Language English (en) Filing Language English (en) Designated States View all Title (EN) LYSERGIC ACID DERIVATIVES WITH MODIFIED LSD-LIKE ACTION (FR) DÉRIVÉS D'ACIDE LYSERGIQUE AYANT UNE ACTION DE TYPE LSD MODIFIÉE front page image
Eight mental health biotech companies trying to make a difference to people’s lives https://www.labiotech.eu/best-biotech/mental-health-companies/ MNMD listed as number 6
HUGE NEWS for Psychedelic Industry Stocks!! FDA Acceptance and Priority Review of New Drug Application for MDMA-Assisted Therapy for PTSD https://news.lykospbc.com/2024-02-0...pplication-for-MDMA-Assisted-Therapy-for-PTSD Lycos is a non-profit that had been studying MDMA for year. Got FDA acceptance for Priority Review. This tide will lift boats like MindMed.
How the United States embraced psychedelics https://english.elpais.com/health/2024-02-13/how-the-united-states-embraced-psychedelics.html
MindMed Reports 2023 Financial Results and Business Updates https://www.businesswire.com/news/home/20240228381905/en/ --Announced statistically significant and clinically meaningful topline Phase 2b data for MM120 at 4 weeks in Generalized Anxiety Disorder (GAD)-- --Multiple planned milestones for MM120 in GAD, including 12-week Phase 2b data to be presented at March 7th investor event, and initiation of Phase 3 clinical program in second half of 2024-- --Initiated Phase 1 clinical trial of MM402 in Autism Spectrum Disorder (ASD)-- --Conference call to discuss year-end financial results at 8:00 a.m. EST-- February 28, 2024 07:05 AM Eastern Standard Time NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ:MNMD), (Cboe Canada:MMED), (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced its financial results for the year ended December 31, 2023 and provided a business update. “MM402 demonstrates better efficacy than S(+)-3,4-MDMA or (±)-3,4-MDMA in Fmr1 knockout mice, an animal model of autism spectrum disorder” “2023 was a highly productive year for MindMed, which concluded with positive Phase 2b results for MM120 in the treatment of adult patients with GAD,” said Rob Barrow, Chief Executive Officer and Director of the Company. “We believe the initial data we shared validates our scientific understanding of MM120’s mechanism of action and shows the potential to have a best-in-class product profile compared to today’s standard of care. We look forward to sharing 12-week safety, efficacy, and durability data and results from our Phase 1 pharmacokinetics bridging trial to support the advancement of our MM120 oral dissolving tablet (ODT) formulation into pivotal clinical trials at our virtual investor event in March. Looking further into 2024, we anticipate several additional milestones, including one-year follow-up results from an investigator-initiated clinical trial of lysergide in anxiety disorders conducted by our collaborators at University Hospital Basel. We will be working closely with the FDA to finalize our Phase 3 development program for MM120 in GAD and expect to hold our End-of-Phase 2 meeting with the FDA in the first half of the year. This is intended to enable the initiation of our Phase 3 clinical program in the second half of the year.” Business Update The Company will host a virtual investor event on March 7, 2024 to provide 12-week data from the Phase 2 program for MM120 being developed for the treatment of GAD. Senior management and key opinion leaders will discuss the treatment landscape, market potential and commercial opportunity for MM120 in GAD and other psychiatric disorders. Program Updates and Anticipated Milestones MM120 (lysergide D-tartrate) for GAD In December 2023, the Company announced statistically significant and clinically meaningful topline 4- week data from the 198-patient Phase 2b dose-optimization trial of MM120 for the treatment of GAD. MM120 100 µg – the dose achieving the highest level of clinical activity – demonstrated a 7.6- point reduction on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4 (-21.3 MM120 vs. -13.7 placebo; p<0.0004; Cohen’s d effect size=0.88), which is more than double the effect sizes seen with the current standards of care1. Clinical response (50% or greater improvement in HAM-A) at Week 4 was achieved in 78% of participants treated with MM120 (100 µg or 200 µg) compared to 31% for placebo. Clinical remission (HAM-A≤ 7) at Week 4 was achieved in 50% of participants treated with MM120 100 µg compared to 18% for placebo. The Company plans to share topline 12-week safety, efficacy, and durability results from the Phase 2b study and results from its pharmacokinetics bridging trial of the MM120 Zydis® ODT formulation, its intended commercial formulation of MM120, at an upcoming virtual investor event on March 7, 2024. The Company anticipates that full results from the Phase 2b trial of MM120 in GAD will be presented at a scientific meeting in 2024. The Company plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 and expects to initiate its Phase 3 clinical program in the second half of 2024. One-year follow-up data from a Phase 2 placebo-controlled investigator-initiated clinical trial of lysergide in the treatment of anxiety disorders is anticipated in 2024. This trial was conducted by the Company’s collaborators at University Hospital Basel (UHB) in Switzerland and completed in Q3 2023. MM402 (R(-)-MDMA) for ASD The Company initiated its first clinical trial of MM402 (R(-)-MDMA), a single-ascending dose trial in adult healthy volunteers in Q4 2023. This Phase 1 trial is intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM402 and should enable further clinical trials to characterize the effects of repeated daily doses of MM402 and the exploration of early signs of efficacy in the ASD population. In October 2023, the Company presented results from a nonclinical study in a model of ASD, titled “MM402 demonstrates better efficacy than S(+)-3,4-MDMA or (±)-3,4-MDMA in Fmr1 knockout mice, an animal model of autism spectrum disorder” at the 36th Annual European College of Neuropsychopharmacology (ECNP) Congress. UHB is currently conducting a Phase 1 investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S- MDMA in healthy adult volunteers. This trial is designed to assess the tolerability, pharmacokinetics and acute subjective, physiological and endocrine effects of the three molecules. The Company anticipates topline results to be presented in the first half of 2024. 2023 Financial Results Cash Balance. As of December 31, 2023, MindMed had cash and cash equivalents totaling $99.7 million compared to $142.1 million as of December 31, 2022. The Company believes its available cash and cash equivalents as well as its committed credit facility are expected to fund operations into 2026, if certain milestones are achieved that unlock additional capital. Net Cash Used in Operating Activities. For the year ended December 31, 2023, net cash used in operating activities was $64.4 million, compared to $50.1 million for the year ended December 31, 2022. Research and Development (R&D). R&D expenses were $52.1 million for the year ended December 31, 2023, compared to $36.2 million for the year ended December 31, 2022, an increase of $15.9 million. The increase was primarily due to increases of $16.1 million in expenses related to clinical research and product development for the MM120 GAD Phase 2b clinical trial, and $2.6 million in internal personnel costs as a result of increasing research and development capacities, offset by a decrease of $0.7 million in expenses related to our MM402 program, a decrease of $0.8 million in expenses related to various external research and development collaborations, and a decrease of $1.2 million in expenses related to preclinical activities and the MM110 program. General and Administrative (G&A). G&A expenses were $41.7 million for the year ended December 31, 2023, compared to $30.2 million for the year ended December 31, 2022, an increase of $11.5 million. The increase was primarily attributable to professional services fees and expenses related to the proxy contest in connection with our 2023 annual general meeting of shareholders and costs to support the growth of our business. Net Loss. Net loss for the year ended December 31, 2023 was $95.7 million, compared to $56.8 million for the year ended December 31, 2022. Conference Call and Webcast Reminder MindMed management will host a conference call at 8:00 AM EST today to provide a corporate update and review the Company’s 2023 financial results. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the Investor Relations section of the MindMed website, https://ir.mindmed.co/, and archived for at least 30 days after the webcast. Those who plan on participating are advised to join 15 minutes prior to the start time. About MM120 Lysergide is a synthetic tryptamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing MM120 (lysergide D-tartrate), the tartrate salt form of lysergide, for GAD and other psychiatric indications. About MM402 MM402 is our proprietary form of R(-)-MDMA (rectus-3,4-methylenedioxymethamphetamine), which we are developing for the treatment of core symptoms of ASD. MDMA is a synthetic molecule that is often referred to as an empathogen because it is reported to increase feelings of connectedness and compassion. Preclinical studies of R(-)-MDMA demonstrate its acute pro-social and empathogenic effects, while its diminished dopaminergic activity suggest that it has the potential to exhibit less stimulant activity, neurotoxicity, hyperthermia and abuse liability compared to racemic MDMA or the S(+)-enantiomer. About MindMed MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine, and acetylcholine systems. MindMed trades on NASDAQ under the symbol MNMD and on the Canadian Cboe Exchange under the symbol MMED. __________________________ 1 Source: RB Hidalgo, J Psychopharmacol. 2007 Nov;21(8):864-72.
MindMed Receives FDA Breakthrough Therapy Designation and Announces Positive 12-Week Durability Data From Phase 2B Study of MM120 for Generalized Anxiety Disorder View source version on businesswire.com:https://www.businesswire.com/news/home/20240307733599/en/ -A single oral administration of MM120 100 µg met its key secondary endpoint and maintained a clinically and statistically significant HAM-A reductions compared to placebo at 12 weeks with a 65% clinical response rate and 48% clinical remission rate- -MindMed plans to hold an End-of-Phase 2 meeting with the U.S. Food & Drug Administration (FDA) in the first half of 2024 and initiate its Phase 3 clinical program in the second half of 2024- -MindMed will host a webcast to discuss data from its Phase 2b study at 8:00 am ET- NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc.(NASDAQ: MNMD), (Cboe Canada MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that FDA has granted breakthrough designation to its MM120 (lysergide d-tartrate) program for the treatment of generalized anxiety disorder (GAD). The Company also announced that its Phase 2b study of MM120 in GAD met its key secondary endpoint, and 12-week topline data demonstrated clinically and statistically significant durability of activity observed through Week 12. MindMed previously announced rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4, which was the trial’s primary endpoint. MM120 was administered as a single dose in a monitored clinical setting with no additional therapeutic intervention. “I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety. That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” stated David Feifel, MD, PhD, Professor Emeritus of Psychiatry at the University of California, San Diego and Director of the Kadima Neuropsychiatry Institute in La Jolla, California and an investigator in the MM120 study. “These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future Phase 3 trials.” MM120 100 µg – the dose with optimal clinical activity observed in the trial – demonstrated a 7.7-point improvement over placebo at Week 12 (-21.9 MM120 vs. -14.2 placebo; p<0.003 Cohen’s d=0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to Week 12. Clinical Global Impressions - Severity (CGI-S) scores on average improved from 4.8 to 2.2 in the 100-µg dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at Week 12 (p<0.004). This clinical activity was rapid, observed as early as study day 2, and durable with further improvements observed in mean HAM-A or CGI-S scores between Weeks 4 and 12. Based on the significant unmet medical need in the treatment of GAD – especially in patients who do not respond to or tolerate currently available medications – along with the initial clinical data from Phase 2b and other research conducted by MindMed, the U.S. Food & Drug Administration (FDA) has designated MM120 for GAD as a breakthrough therapy. The Company plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 and initiate a Phase 3 clinical program in the second half of 2024. “The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our Phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “We are committed to bringing MM120 to people living with GAD and delivering on the potential of our pipeline to treat serious brain health disorders.” In the Phase 2b study, known as MMED008, MM120 was generally well-tolerated with most adverse events rated as mild to moderate, transient and occurring on dosing day, and being consistent with expected acute effects of the study drug. The most common adverse events (at least 10% incidence in the high dose groups) on dosing day included illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis and hyperhidrosis. Prior to treatment with MM120, study participants were clinically tapered and then washed out from any anxiolytic or antidepressant treatments and did not receive any form of study-related psychotherapy for the duration of their participation in the study. “As a clinician and clinical researcher, I applaud the way this study was designed by MindMed to isolate the effect of MM120 by removing confounding variables like additional medications and psychotherapy,” said Reid Robison, MD, Psychiatrist and Chief Clinical Officer at Numinus (TSX:NUMI) who has served as adjunct faculty at the University of Utah for the last 12 years and was an investigator in the MM120 study. “It gives me confidence in the data and the positive results give me hope that this may translate into meaningful benefits for my patients.” The primary data analyses from MMED008 have been accepted for presentation at the American Psychiatric Association’s annual meeting, which will be held in New York on May 4-8, 2024. The study is also being submitted for publication in a leading medical journal. Conference Call and Webcast MindMed management will host a webcast at 8:00 am ET today to discuss the Phase 2b results of MM120 in GAD. The webcast and slides will be accessible live under “News & Events” on the Investors page of the Company’s website athttps://ir.mindmed.co/or by clickinghere. A replay of the event will be available on MindMed’s website. The webcast will be archived on the Company’s website for at least 30 days after the conference call. About Generalized Anxiety Disorder (GAD) GAD is a common condition associated with significant impairment that adversely affects millions of people. GAD results in fear, persistent anxiety and a constant feeling of being overwhelmed. It is characterized by excessive, persistent, and unrealistic worry about everyday things. Approximately 10% of U.S. adults, representing around 20 million people, currently suffer from GAD, an underdiagnosed and underserved indication that is associated with significant impairment, less accomplishment at work and reduced labor force participation. Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2004. About MMED008 MMED008 was a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial enrolled 198 participants who were randomized to receive a single administration of MM120 at a dose of 25, 50, 100 or 200 µg or placebo. The full analysis set (FAS) for the trial included 194 subjects, those that had at least one valid post-baseline Hamilton Anxiety rating scale (HAM-A) score. Subjects enrolled in the trial presented with severe GAD symptoms (average baseline HAM-A scores of approximately 30). The study's main objective was to determine the dose-response relationship of four doses of MM120 versus placebo as measured by the change in HAM-A from Baseline to Week 4. The key secondary objective of the study was to determine the dose-response relationship of four doses of MM120 versus placebo as measured by the change in HAM-A from Baseline to Week 8. Secondary objectives, measured up to 12 weeks after the single administration, include assessments of anxiety symptoms, safety and tolerability, and other measures of efficacy and quality of life. More information about the trial is available on the MindMed website (mindmed.co) or on clinicaltrials.gov (NCT05407064). About MM120 Lysergide is a synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing MM120 (lysergide D-tartrate), the tartrate salt form of lysergide, for GAD and is exploring its potential applications in other serious brain health disorders. About MindMed MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders. MindMed trades on NASDAQ under the symbol MNMD and on the Cboe Canada (formerly known as the NEO Exchange, Inc.) under the symbol MMED.
Government going to deschedule cannabis. This is big for this sector because of optics. MNMD poised to be back to fair market value prior to Phase 3. Good play here.
MindMed Announces Constructive End-of-Phase 2 Meeting with U.S. FDA for MM120 in Generalized Anxiety Disorder (GAD) -Aligned on requirements for Phase 3 clinical development of MM120 for the treatment of GAD- -Initiation of Phase 3 program remains on schedule to begin in second half of 2024- https://www.businesswire.com/news/home/20240620626324/en/ June 20, 2024 07:00 AM Eastern Daylight Time NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced the completion of the End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of MM120 (lysergic acid diethylamide [LSD] D-tartrate) into pivotal trials for the treatment of adults with GAD. “On behalf of the 20 million people in the U.S. – and millions more worldwide – who are living with GAD, we are incredibly excited for the therapeutic potential that MM120 shows based on the data from the previously completed Phase 2b MMED008 trial” Post this “Following a constructive End-of-Phase 2 meeting with the FDA, we are pleased to have reached alignment on our Phase 3 development strategy for MM120 in GAD,” said Rob Barrow, Chief Executive Officer of MindMed. “This marks a significant milestone for MindMed and for the millions of individuals affected by GAD. We are on schedule to initiate our Phase 3 clinical program for MM120 oral dissolving tablet (ODT) in GAD in the second half of this year and look forward to sharing additional details on the design of our pivotal program in the coming months.” The EOP2 meeting was supported by results from MindMed’s completed Phase 2b clinical trial, MMED008. The multi-center, randomized, double-blind, parallel-group, dose-finding study was designed to assess the effect of four doses of MM120 for the treatment of anxiety symptoms in participants diagnosed with GAD. In the trial, MM120 met its primary and key secondary endpoints and demonstrated a rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety rating scale (HAM-A) at Week 4 and Week 12, with a 65% clinical response rate and 48% clinical remission rate sustained to Week 12 in the MM120 100 µg cohort. MM120 was generally well-tolerated in this trial, with most adverse events rated as mild to moderate, transient, and occurring on the dosing day and being consistent with the expected acute effects of the trial drug. “On behalf of the 20 million people in the U.S. – and millions more worldwide – who are living with GAD, we are incredibly excited for the therapeutic potential that MM120 shows based on the data from the previously completed Phase 2b MMED008 trial,” said Daniel R. Karlin, MD, MA, Chief Medical Officer of MindMed. “Few treatment options have shown robust activity in GAD, with the last new FDA approval occurring in 2007. We are committed to bringing MM120 to people living with GAD and are excited to move into the next phase of our development program.” About MM120 LSD (lysergide) is a synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing MM120, the tartrate salt form of lysergide, for GAD and is exploring its potential applications in other serious brain health disorders. About Generalized Anxiety Disorder (GAD) GAD is a common condition associated with significant impairment that adversely affects millions of people. GAD results in fear, persistent anxiety, and a constant feeling of being overwhelmed. It is characterized by excessive, persistent, and unrealistic worry about everyday things. Approximately 10% of U.S. adults, representing around 20 million people, currently suffer from GAD. This underdiagnosed and underserved indication is associated with significant impairment, less accomplishment at work and reduced labor force participation. Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2007. About MindMed MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders. MindMed trades on NASDAQ under the symbol MNMD.
MindMed to be Included in Russell 2000® and Russell 3000® Indexes https://www.businesswire.com/news/h...ed-in-Russell-2000®-and-Russell-3000®-Indexes June 28, 2024 07:00 AM Eastern Daylight Time NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced today that as part of the annual reconstitution of the Russell stock indexes, the Company will be included in the Russell 2000® Index and the broad-market Russell 3000® Index, effective today. “We are pleased to join the Russell Indexes and look forward to continuing to share our story with a broader audience of investors.” Post this “MindMed’s inclusion in the Russell Indexes mark an exciting milestone and reflects growing recognition of our commitment to addressing the unmet medical needs for people with brain health disorders by advancing MM120 for the treatment of general anxiety disorder and MM402 for the treatment of autism spectrum disorder,” said Rob Barrow, Chief Executive Officer of MindMed. “We are pleased to join the Russell Indexes and look forward to continuing to share our story with a broader audience of investors.” Membership in the Russell 3000® Index means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index as well as in the appropriate growth and value style indexes. The Russell 3000® Index encompasses the 3,000 largest U.S.-traded stocks by objective, market-capitalization rankings, and style attributes. Membership in these indexes is updated annually and remains in place for one year. The Russell Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9.1 trillion in assets are benchmarked against Russell's U.S. Indexes. Russell Indexes are part of FTSE Russell, a leading global index provider. For more information on the Russell Indexes and the Russell U.S. Indexes Reconstitution, visit the "Russell Reconstitution" section on the FTSE Russell website. About MindMed MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine, and acetylcholine systems.
MNMD - MindMed - Patent July 19 - LYOPHILIZED ORALLY DISINTEGRATING TABLET FORMULATIONS OF d-LYSERGIC ACID DIETHYLAMIDE FOR THERAPEUTIC U.S. PATENT DOCUMENT https://ppubs.uspto.gov/dirsearch-public/print/downloadPdf/12036220
Official press release from the patent issued yesterday https://finance.yahoo.com/news/mindmed-announces-issuance-patent-mm120-110000178.html
