New Patent: ($MNMD) USING GENO- OR PHENOTYPING TO ADJUST LSD DOSING https://appft.uspto.gov/netacgi/nph...&S1=20220280501&OS=20220280501&RS=20220280501 Patent Alert! A new U.S. patent application No. 20220280501 was published yesterday containing broad claims regarding the use of #genetic and #metabolic assessment to determine #sd #dosing. Prior art can be found at http://portasophia.org
Signaling snapshots of a serotonin receptor activated by the prototypical psychedelic LSD https://www.cell.com/neuron/fulltext/S0896-6273(22)00752-8#relatedArticles Bryan Roth is on MindMed's team: https://www.prnewswire.com/news-rel...h-to-scientific-advisory-board-301387396.html
Here is the full link: https://appft.uspto.gov/netacgi/nph...&S1=20220280501&OS=20220280501&RS=20220280501
Miami clinic kicks off first national study of LSD (MM-120), once a ‘public enemy,’ to treat anxiety https://www.miamiherald.com/news/health-care/article266041696.html
January 2023 - Investor Presentation & Corporate Outlook Investor Presentation - https://mindmed.co/wp-content/uploads/2023/01/MindMed-Investor-Presentation_Jan2023.pdf Corporate Outlook PR - https://www.prnewswire.com/news-rel...porate-update-and-2023-outlook-301716173.html MindMed Provides Corporate Update and 2023 Outlook News provided by Mind Medicine (MindMed) Inc. Jan 09, 2023, 07:30 ET - Company positioned for key MM-120 Phase 2b data readout in GAD and Phase 2a data readout in ADHD in late 2023 - Company to initiate first clinical trial of MM-402 in 2023 - Cash runway to fund current operating plan into first half of 2025 - Company to host a virtual analyst and investor day in the first half of 2023 NEW YORK, Jan. 9, 2023 /PRNewswire/ -- 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 2023. "Following a year of continued strong execution, our progress in 2022 has set the stage for a meaningful 2023, a year in which we plan to further elucidate the potential of our MM-120 product candidate in generalized anxiety disorder (GAD) and initiate the first clinical trial for our MM-402 program," stated Rob Barrow, Chief Executive Officer. "Our focus remains on advancing and unlocking the value of our proprietary product candidates, which we believe have the potential to deliver new, life-changing therapies to people living with brain health disorders. There are several key milestones over the next twelve months that can be used to measure our progress. This year we expect key data readouts from our Phase 2b study of MM-120 for the treatment of generalized anxiety disorder, as well as from our Phase 2a proof-of-concept trial of repeated low-dose MM-120 in attention-deficit/hyperactivity disorder (ADHD). Additionally, we expect to initiate the first clinical trial of MM-402 later in the year. Importantly, we believe our strong financial position provides us with the ability to fund our programs well beyond these key milestones and into the first half of 2025." Business Update: - The Company reiterates its guidance for its cash runway, which is expected to fund the current operating plan into the first half of 2025. - MindMed's management team will participate in the BIO Partnering at JPM event in San Francisco that is being held from January 9-12, 2023. - The Company expects to host a virtual analyst and investor day in the first half of 2023. The event will be hosted by the Company's management team and will include a physician expert and other leading key opinion leaders. Development Program Updates and Anticipated Milestones: Phase 2b study evaluating MM-120 for generalized anxiety disorder (GAD) remains on track - MM-120 (LSD D-tartrate), the Company's proprietary, pharmaceutically optimized form of lysergic acid diethylamide (LSD), is being developed primarily for the treatment of GAD. - In August 2022, the Company initiated patient dosing in the 200-patient Phase 2b dose-optimization study of MM-120 for the treatment of GAD. - Patient enrollment is currently ongoing and the study remains on track, with topline results expected to be announced in late 2023. Phase 2a study evaluating MM-120 for ADHD remains on track - The Company's 52-patient Phase 2a proof-of-concept trial for the treatment of ADHD is designed to assess the safety and efficacy of repeated low-dose MM-120 administration. - The Company expects topline results in late 2023. Advancing development of MM-402 into first clinical trial in 2023 - The Company is developing MM-402, the R-enantiomer of 3,4-Methylenedioxymethamphetamine (MDMA), for the treatment of core symptoms of autism spectrum disorder (ASD). - Results of MM-402's effects in a preclinical model of ASD are expected to be presented in the first half of 2023. - The Company plans to initiate its first clinical trial of MM-402 in 2023. This Phase 1 study is intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM-402, and to provide early signals of efficacy to support the Company's approach in targeting core symptoms of ASD. - University Hospital Basel in Switzerland, the Company's collaborator, is currently enrolling a Phase 1 trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA in healthy volunteers. This trial is comparing the tolerability, pharmacokinetics and acute subjective, physiological and endocrine effects of the three molecules. 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.
Study Completed - LSD Therapy for Persons Suffering From Major Depression (LAD) https://clinicaltrials.gov/ct2/show/NCT03866252
LSD Therapy for Persons Suffering From Major Depression (LAD) ClinicalTrials.gov Identifier: NCT03866252 Recruitment Status : Completed First Posted : March 7, 2019 Last Update Posted : January 26, 2023 Sponsor: University Hospital, Basel, Switzerland Collaborator: Department of Psychiatry Basel (UPK Basel; Prof. Dr. med. Stefan Borgwardt) Information provided by (Responsible Party): University Hospital, Basel, Switzerland Study Description Go to Brief Summary: Background: Major Depressive Disorder is one of the most prevalent mental illnesses, leading to substantial personal distress and economical consequences. Pharmacological Treatment is limited and relapse is frequent. Lysergic acid diethylamide (LSD) was extensively investigated in humans in the 1950s and 1960s and was shown to attenuate depressive symptoms. Clinical research with LSD ended in the 1970s due to regulatory restrictions but its use for personal and recreational purposes continued. In recent years, there has been a renewed interest in the use of hallucinogens in psychiatric research and practices, reconsidering LSD's antidepressant potential. Larger, well-designed and placebo-controlled studies are warranted. This study will evaluate the potential benefits of LSD-assisted psychotherapy in patients suffering from Major Depressive Disorder. Objective: To test the efficacy of LSD in patients with Major Depressive Disorder. Design: Randomised, double-blind, active-placebo-controlled trial using either two moderate to high doses of LSD (100 µg and 100 µg or 100 µg and 200 µg) as intervention and two low doses of LSD (25 µg and 25 µg) as active-placebo control. Participants: 60 patients aged > 25 years with Major Depressive Disorder (according to DSM-V). Main outcome measures: Change in depressive symptomatology (IDS-SR, BDI), anxiety (STAI), and general psychopathology (SCL-90) compared with active-placebo-assisted psychotherapy. Condition or disease Intervention/treatment Phase Major Depressive Disorder Drug: LSD Phase 2 Ages Eligible for Study: 25 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) > 25 years Sufficient understanding of the German language Exclusion Criteria: < 25 years Concomitant diagnosis of past or present psychotic disorder Concomitant diagnosis of past or present bipolar disorder First degree relative with a psychotic disorder Unable or unwilling to discontinue antidepressant medication Pregnancy or breastfeeding Known hypersensitivity to LSD Somatic disorders including central nervous system (CNS) involvement Known or suspected non-compliance, drug or alcohol abuse Metal implants Weight < 42 kg Suicide risk or very likely to require psychiatric hospitalisation NCT03866252 History of Changes Other Study ID Numbers: BASEC 2018-02370 First Posted: March 7, 2019 Key Record Dates Last Update Posted: January 26, 2023 Last Verified: January 2023 Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Product Manufactured in and Exported from the U.S.: No Additional relevant MeSH terms: Depressive Disorder Depressive Disorder, Major Mood Disorders Mental Disorders Lysergic Acid Diethylamide Hallucinogens Physiological Effects of Drugs Psychotropic Drugs Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Receptor Agonists
Basel initiates a new DMT study Phase 1 https://clinicaltrials.gov/ct2/show/NCT05695495 Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects (DMT BDR-Study) (DMT BDR) Contact: Matthias E Liechti Brief Summary: N,N-dimethyltryptamine (DMT) is a psychoactive substance with similar effects such as LSD or psilocybin. However, DMT is less well characterized than the latter substances. The present study is a modern randomized cross-over trial, investigating different intravenous DMT boluses over a broad dose range. Thus, different doses will be tested and related to subjective and autonomic effects. Detailed Description: N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings (Ayahuasca). DMT is considered a tool to induce an altered state of consciousness of interest in psychological and psychiatric research. DMT is rapidly metabolized by monoamine oxidase (MAO) A. Therefore, it is inactive when administered orally and has a very short duration of action when administered parenterally (<20 min). However, to date no clinical study has investigated dose-response effects over a broad range of different doses of DMT within the same patient. The aim of the present study is to experimentally test different intravenous DMT bolus doses over a broad dose range and investigate the related subjective and autonomic effects in order to establish a precise dose-response relationship of DMT in healthy subjects.
Psychedelics May Be Part of U.S. Medicine Sooner Than You Think https://time.com/6253702/psychedelics-psilocybin-mdma-legalization/ BY JAMIE DUCHARME FEBRUARY 8, 2023 1:07 PM EST It came as a surprise to many when, on Feb. 3, Australian regulators announced that medicines containing the psychedelic substances MDMA and psilocybin can soon be used there to treat post-traumatic stress disorder (PTSD) and treatment-resistant depression, respectively. That decision makes Australia the first country in the world to formally recognize the therapeutic use of psychedelics. Other countries, including the U.S., may be headed toward a similar outcome, some experts say. Research increasingly suggests that psychedelics can be powerful tools for treating a variety of mental-health conditions, from PTSD and depression to addiction and eating disorders. “I’ve been doing this for 11 years,” says Albert Perez Garcia-Romeu, an assistant professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine who studies psychedelics. “The overwhelming majority of people that I’ve worked with in this process have been helped by their experiences, and the data are remarkably consistent.” In Nov. 2022, the U.S. nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) announced that it had completed a second phase-three trial on MDMA as a treatment for PTSD—a step widely seen as the last hurdle to clear before applying for approval from the U.S. Food and Drug Administration (FDA). While the data from that study have yet to be published in a peer-reviewed journal, MAPS says its findings echo the positive results from its first phase-three MDMA trial, published in the journal Nature Medicine in 2021, which found that PTSD patients who took MDMA while also undergoing therapy reported significant improvements in their symptoms 18 weeks after their first dose, compared to those who received a placebo. Rick Doblin, MAPS’ founder and executive director, says his group is preparing to apply for FDA approval based on those data. If all goes well, he says, the drug could be approved as soon as 2024. Research on psilocybin, the psychoactive component in “magic” mushrooms, may take a little longer to progress to that stage, Garcia-Romeu says, but he expects psilocybin to be considered for FDA approval within the next few years. In Nov. 2022, results from a phase-two psilocybin trial were published in the New England Journal of Medicine. They found that a single 25-milligram dose of psilocybin eased symptoms among people with treatment-resistant depression over a period of three weeks, though it did come with side effects including headaches, nausea, and dizziness. Australia’s approval of these drugs, Doblin says, may only expedite the approval process in the U.S. “It’s going to help regulators in the U.S. and elsewhere feel more comfortable,” he says. “Regulators don’t like to be the first or the only ones.” A representative for the FDA did not respond to TIME’s request for comment before press time. But in a May 2022 letter first published by the Intercept, a U.S. Department of Health and Human Services official wrote that FDA approval of MDMA and psilocybin was “anticipated” within “approximately 24 months.” Read More: Inside Ibogaine, One of the Most Promising and Perilous Psychedelics for Addiction The FDA has also previously granted “breakthrough therapy” status to MDMA and psilocybin. That designation recognizes a drug’s therapeutic potential and is meant to streamline the road from research to approval. The agency has also allowed a limited number of people to use MDMA under what’s known as “expanded access,” a program meant to help seriously ill patients who have not responded to other treatments try drugs that are still being studied. Regulators in other countries have made similar decisions. Switzerland, Canada, and Israel allow clinicians to use certain psychedelics under specific circumstances for patients with severe conditions. Jamaica and Costa Rica, among other countries, also already operate legal psilocybin clinics. Some U.S. states have embraced the use of psychedelics, too. Psilocybin use became legal in Oregon on Jan. 1 when used by adults under the supervision of a licensed facilitator, and Colorado residents recently voted to do the same. Legislation to legalize psilocybin has also been introduced in states including Connecticut, New Jersey, and California. Australia, however, will be the first country in the world to make psychedelics available for medicinal use at a national level, starting July 1. But access to the drugs won’t be as straightforward as it is for other prescription medications. Despite their decision to make MDMA and psilocybin available to patients, Australian regulators have not approved any medications that contain these substances. To prescribe drugs that are technically still unapproved, psychiatrists must apply to become authorized prescribers—a process that involves securing approval from both Australia’s Therapeutic Goods Administration (TGA) and a human research ethics committee, and obtaining a permit to import the drugs from Australia’s Office of Drug Control. That’s a “deviation” from standard process, says Dr. Michael Bogenschutz, director of the NYU Langone Center for Psychedelic Medicine. “Allowing [a drug] to be used as though it already had been approved is what I would be concerned about.” While Bogenschutz is excited by the advances in psychedelics research, and says it’s “looking more and more like these drugs may find their place in medicine,” he’s concerned about enthusiasm outpacing science. “We hope [psychedelics] will represent a major breakthrough, but we really can’t say that is true until we’ve accumulated and analyzed the evidence that is needed to make that determination,” he says. Australia’s TGA acknowledged in its Feb. 3 announcement that “there is only limited evidence that the substances are of benefit in treating mental illnesses,” but maintained that “there is a need for access to new therapies for treatment-resistant conditions.” Doblin says his concern with Australia’s plan is whether authorized psychiatrists will receive adequate training. “The drug is not the treatment,” he says. “The drug makes the therapy more effective, but it’s about the therapy.” MAPS’ leadership has recommended to U.S. regulators that therapists complete a 100-hour training program before they can use MDMA to treat patients. That caution is primarily to ensure that patients are getting the best care, but also to help the drugs’ rollout goes as smoothly as possible. “Things that happen in one country are really broadcast around the world,” Doblin says. That means whatever happens in Australia, for better or for worse, could have ripple effects for countries all around the globe.
February 2023 Investor Deck https://mindmed.co/wp-content/uploads/2023/02/MindMed-Investor-Presentation_Feb2023.pdf
CNBC covering Psychedelics Psychedelics such as psilocybin, ketamine, LSD and MDMA are lately being discussed because of their alleged potential to treat mental health disorders. As interest from the medical community and investors grows, what’s next for the psychedelic therapy market? https://twitter.com/CNBCi/status/1626212109737660417 BULLISH
Most members of Congress and thousands of government employees are enrolled in the clinical trials for psychedelic therapy drugs - this explains A LOT!
MindMed CEO Rob Barrow lays out the Company's upcoming milestones and strategy in a new interview with Edison Group
MindMed Reports Full Year 2022 Financial Results and Business Highlights https://mindmed.co/news/press-relea...22-financial-results-and-business-highlights/ – Company positioned for key MM-120 Phase 2b data readout in GAD and Phase 2a data readout in ADHD in late 2023 – – Company to initiate first clinical trial of MM-402 in 2023 – – Cash and cash equivalents of $142.1 million at December 31, 2022 – – Company to host conference call today at 4:30 PM ET – NEW YORK, March 9, 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 reported its financial results for the full-year ended December 31, 2022. “Our significant progress in 2022 has set the stage for what we expect to be a transformational 2023,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “This year we expect key data readouts from our Phase 2b study of MM-120 for the treatment of generalized anxiety disorder, as well as from our Phase 2a proof-of-concept trial of repeated low-dose MM-120 in attention-deficit/hyperactivity disorder. Additionally, we expect to initiate the first clinical trial of MM-402 later in the year. Importantly, we believe our financial position provides us with the ability to fund our programs well beyond these key milestones and into the first half of 2025. I am incredibly proud of our team’s achievements, and I am more confident than ever in our ability to continue advancing our organization and development programs. We are keenly focused on our mission to deliver novel therapies to treat brain health disorders, which we believe will lead to meaningful improvements in patient outcomes in these major areas of unmet medical need.” Business Update – The Company reiterates its guidance for its cash runway, which is expected to fund its current operating plan into the first half of 2025. – MindMed’s management team will participate in the 33rd Annual Oppenheimer Healthcare Conference that is being held virtually from March 13-15, 2023 as well as the 35th Annual Roth Conference in Laguna Niguel, CA from March 12-14, 2023. – The Company expects to host a virtual analyst and investor day in the first half of 2023. The event will be hosted by the Company’s management team and will include a physician expert and other key opinion leaders. Recent Highlights and Anticipated Upcoming Milestones: Phase 2b study evaluating MM-120 for generalized anxiety disorder (“GAD”) remains on track – MM-120, the Company’s proprietary, pharmaceutically optimized form of lysergide D-tartrate, is being developed for the treatment of GAD. – In August 2022, the Company initiated dosing in the 200-patient Phase 2b dose-optimization study of MM-120 for the treatment of GAD. – Patient enrollment is currently ongoing, and the study remains on track, with topline results expected to be announced in late 2023. Phase 2a study evaluating MM-120 for attention deficit hyperactivity disorder (“ADHD”) remains on track – The Company’s Phase 2a proof-of-concept trial for the treatment of ADHD is designed to assess the safety and efficacy of repeated low-dose MM-120 administration in 52 patients. – The Company expects topline results in late 2023. Advancing development of MM-402 into first clinical trial in 2023 – The Company is developing MM-402, the Company’s proprietary form of the R-enantiomer of 3,4-Methylenedioxymethamphetamine (“MDMA”), for the treatment of core symptoms of autism spectrum disorder (“ASD”). – Results from a preclinical study of MM-402 in a model of ASD are expected to be presented in the first half of 2023. – The Company plans to initiate its first clinical trial of MM-402 in 2023. This Phase 1 study is intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM-402, and to evaluate early signals of efficacy to support the Company’s approach in targeting core symptoms of ASD. – University Hospital Basel (“UHB”) in Switzerland, the Company’s collaborator, is currently enrolling patients in a Phase 1 investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA in healthy volunteers. This trial is comparing the tolerability, pharmacokinetics and acute subjective, physiological and endocrine effects of the three molecules. Collaborations and Partnerships The Company continues to support its ongoing collaboration with the Liechti Lab at University Hospital Basel (“UHB”) in Switzerland. MindMed has exclusive worldwide rights to data, compounds and patent rights associated with UHB’s research on lysergide and other psychedelic compounds, including data from preclinical studies and investigator-initiated clinical trials. In September 2022, UHB published the results of a randomized, double-blind, placebo-controlled Phase 2 study in the peer-reviewed scientific journal, Biological Psychiatry. Topline results in 46 patients with clinically significant anxiety demonstrated the significant, rapid, durable and beneficial effects of lysergide and its potential to mitigate symptoms of anxiety and depression with an acceptable tolerability profile. The Company believes these results support the continued clinical development of lysergide. In November 2022, the peer-reviewed publication of a double-blind, placebo-controlled, random-order, two-period crossover investigator-initiated trial of lysergide and ketanserin was published in the International Journal of Neuropsychopharmacology. The study demonstrated the potential of ketanserin to shorten and attenuate the perceptual effects of lysergide. 2022 Financial Results Cash Balance. As of December 31, 2022, MindMed had cash and cash equivalents totaling $142.1 million compared to $133.5 million as of December 31, 2021. The Company believes its available cash and cash equivalents will be sufficient to fund its operating requirements into the first half of 2025. Net Cash in Operating Activities. The net cash used in operating activities was $50.1 million for the year ended December 31, 2022, compared to $45.8 million in the year ended December 31, 2021. Research and Development (R&D). R&D expenses were $36.2 million for the year ended December 31, 2022, compared to $34.8 million for the year ended December 31, 2021, an increase of $1.4 million. The increase was primarily due to increases of $2.9 million in expenses related to clinical research for MM-120, and $5.4 million in internal personnel costs as a result of increasing research and development capacities, offset by a decrease of $5.6 million in expenses related to the Company’s MM-110 program, and a decrease of $2.4 million of expenses in connection with various external R&D collaborations. General and Administrative (G&A). G&A expenses were $30.2 million for the year ended December 31, 2022, compared to $59.1 million for the year ended December 31, 2021, a decrease of $28.9 million. The decrease was primarily due to a decrease of $27.4 million in non-cash stock-based compensation expenses primarily relating to the modification of stock option awards and RSUs recorded during the year ended December 31, 2021. Net Loss. Net loss for the year ended December 31, 2022 was $56.8 million, compared to $93.0 million for the same period in 2021. Conference Call and Webcast Reminder MindMed management will host a conference call at 4:30 PM EST today to provide a corporate update and review the Company’s fiscal year 2022 financial results. Individuals may participate in the live call via telephone by dialing (888) 886-7786 (domestic) or (416) 764-8658 (international) and using conference ID 09516401 or by clicking on this link and requesting a return call. The webcast can be accessed live here on the Financials 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 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 Canadian NEO Exchange under the symbol MMED.
