London Healthcare Week: As the company gears up for its first phase 3 trials, MindMed's CEO says he sees a tailwind of regulatory support for the psychedelics space https://www.biotechtv.com/post/mindmed-november-22-2024 Video Interview in link
MindMed Appoints Javier Muniz, M.D., as Vice President of Research and Development Strategy https://www.businesswire.com/news/home/20241203094211/en/ 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 appointment of Javier A. Muniz, M.D., as Vice President of Research and Development (R&D) Strategy. In his new role, Dr. Muniz will drive innovation and growth of MindMed’s R&D operations as the Company prepares to initiate three Phase 3 studies of MM120 orally disintegrating tablet (ODT) in generalized anxiety disorder and major depressive disorder. “Javier’s extensive expertise leading interdisciplinary scientific teams at the U.S. Food and Drug Administration (FDA), combined with his deep experience within the uniformed services in the fields of neuroscience and psychiatry makes him a welcome addition to the MindMed team,” said Dan Karlin, M.D., M.A., Chief Medical Officer of MindMed. “His leadership will play an important role in strengthening our R&D operations as we advance the therapeutic potential of our pipeline, prepare for two potential approvals and aim to reshape the treatment landscape for people living with brain health disorders.” Dr. Muniz will report to Dr. Karlin. “I am thrilled to join MindMed at such a pivotal moment in the Company’s history, with potential approvals of MM120 ODT for multiple indications on the horizon,” said Dr. Muniz. “The groundbreaking science and purpose-driven culture made this a unique and compelling opportunity. I look forward to advancing our pipeline and ushering in psychedelics as a potential transformational treatment paradigm in psychiatry.” Javier A. Muniz, M.D. Dr. Muniz is an expert in psychiatry, regulatory science, and drug development, with more than 20 years of experience in the uniformed services. He served 11 years at the FDA as a member of the U.S. Public Health Service, where he held roles including clinical team leader, associate director, acting deputy director, and supervisory health scientist. He provided regulatory oversight for innovative psychiatric drug development programs, including first-in-class treatments, the first “digital” pill, and breakthrough therapy-designated programs. He also co-authored several guidance for industry documents. Dr. Muniz is a recognized thought leader in psychedelic and entactogen-based therapies, having presented at numerous national and international conferences on scientific and regulatory challenges. Before the FDA, he served in the U.S. Air Force, directing psychiatric programs at Andrews Air Force Base, and Fort Meade, MD, where he supported national security missions, led rapid-response teams for the U.S. Department of Health and Human Services, and provided care to Wounded Warriors. Dr. Muniz completed his undergraduate and medical degrees in Puerto Rico and his psychiatry residency at Mount Sinai Medical Center in New York City. He is board-certified in psychiatry and has received numerous awards, including two Presidential Unit Citations, the Meritorious Service Medal, and the Afghanistan Campaign Medal.
MindMed Awarded Innovation Passport Designation by the United Kingdom (UK) Innovative Licensing and Access Pathway (ILAP) Steering Group for MM120 Orally Disintegrating Tablet (ODT) for Generalized Anxiety Disorder (GAD) https://ir.mindmed.co/news-events/p...blet-odt-for-generalized-anxiety-disorder-gad Dec 05, 2024 7:00 am EST Download as PDF - Innovation Passport Designation Aims to Accelerate Time to Market and Facilitate Patient Access to Innovative Medicines - 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 that MM120 ODT, a pharmaceutically optimized form of lysergide D-tartrate (LSD), has been granted an Innovation Passport for the potential treatment of GAD under ILAP by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). The Innovation Passport is the entry point to the ILAP, which aims to accelerate time to market and facilitate patient access to medicines in the U.K. “Receiving the Innovation Passport designation is recognition of MM120 ODT’s potential to address GAD, one of the most critical and underserved needs in mental health,” said Rob Barrow, Chief Executive Officer of MindMed. “Following the receipt of Breakthrough Therapy Designation by the U.S. Food and Drug Administration, the Innovation Passport designation underscores our commitment to bringing MM120 ODT to people living with GAD and our dedication to working closely with the MHRA to expedite patient access. We are determined to offer new hope and transformative solutions where current treatments have failed to meet the needs of those who suffer from this serious condition.” Recipients of the Innovation Passport are granted access to a range of development tools to support the design, development, and approvals process in the U.K., as well as opportunities for enhanced regulatory and other stakeholder input. Specific benefits of ILAP include the potential for a 150-day accelerated Marketing Authorization Application assessment, rolling review and a continuous benefit risk assessment. The ILAP is delivered in partnership by the MHRA, the All Wales Therapeutics and Toxicology Centre, the National Institute for Health and Care Excellence and the Scottish Medicines Consortium, part of Healthcare Improvement Scotland.
Psychedelic Clinical Trials: Regulatory Considerations from the FDA https://www.nationalacademies.org/documents/embed/link/LF2255DA3DD1C41C0A42D3BEF0989ACAECE3053A6A9B/file/DC13F898D77B1738F10CD41B1FB160CB84D5802C8F6F?noSaveAs=1 Javier A. Muniz, M.D. Commander, USPHS Associate Director of Therapeutic Review Division of Psychiatry, Office of New Drugs Center for Drug Evaluation and Research US Food and Drug Administration
MindMed Announces First Patient Dosed in Phase 3 Voyage Study of MM120 in Generalized Anxiety Disorder (GAD) https://www.businesswire.com/news/home/20241216046321/en/ - Voyage is the first-ever Phase 3 study of lysergide D-tartrate (LSD) with the primary endpoint measuring the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) score at week 12 for MM120 Orally Disintegrating Tablet (ODT) 100 µg vs placebo - - Study builds on positive Phase 2b study results presented at the American Psychiatric Association’s Annual Meeting in May 2024 - - Topline data from the 12-week double-blind period anticipated in the first half of 2026 -
MindMed to Be Added to the Nasdaq Biotechnology Index https://www.businesswire.com/news/home/20241219955108/en/ Corporate Presentation December 2024 https://d1io3yog0oux5.cloudfront.ne...dMed+Investor+Presentation+December+2024+.pdf
Docket Number: FDA-2023-D-1987: Psychedelic Drugs: Considerations for Clinical Investigations; Draft Guidance for Industry; Availability https://downloads.regulations.gov/FDA-2023-D-1987-0197/attachment_1.pdf Also, while this is older, I didn't uncover until now. Everyone should read this in full but here is the overview. Bullet Point Synopsis: Introduction & Purpose: MindMed appreciates the FDA's draft guidance on psychedelic drugs and supports the goal of facilitating their safe and effective development. MindMed is a clinical-stage biopharmaceutical company focusing on psychedelic and non-psychedelic therapies for mental and behavioral health conditions. MindMed's Expertise: Lead candidates include proprietary forms of LSD and R-enantiomer of MDMA. MindMed expresses interest in collaborating with the FDA to enable the approval process. Key Focus Area: The comments center on clinical considerations, particularly selecting appropriate controls for adequate and well-controlled (AWC) studies. Draft Guidance Analysis: Line 271 acknowledges challenges with traditional placebo controls in psychedelic trials due to: Functional unblinding (perceptual disturbances revealing active treatment). Expectation bias or nocebo effects in placebo recipients. Alternative controls (e.g., subperceptual doses, niacin, diphenhydramine) have significant validity issues and amplify functional unblinding risks. Critique of Alternatives: Active controls (like niacin or diphenhydramine) may produce distinguishable effects, undermining blinding. Subperceptual doses of psychedelics fail to address unblinding issues and complicate safety and efficacy assessments. Support for Placebo Controls: Placebo concurrent control (inactive placebo) remains the gold standard for maintaining internal and external validity in trials. Historical use of placebos in CNS-active agent trials (e.g., Spravato, psychostimulants) demonstrates their efficacy despite perceptual effects. Recommendations: FDA should maintain the gold standard of traditional/inert placebos for all adequate, well-controlled trials of psychedelic drugs. Dose-response studies, while valuable, should not replace placebo-controlled studies for establishing definitive clinical efficacy.
Woman free of anxiety meds 1 year after Cleveland Clinic LSD trial success https://www.cleveland.com/medical/2...after-cleveland-clinic-lsd-trial-success.html Barnett expects LSD to be approved as a psychiatric treatment by 2027 -- with intensive training and logistics before the treatment can be rolled out."
Phase 3 Trial of MM120 for Generalized Anxiety Disorder (VOYAGE) - Trial Page https://www.reddit.com/r/MindMedInv...ase_3_trial_of_mm120_for_generalized_anxiety/
Defying Industry Setbacks, MindMed Advances Psychedelic To Phase 3 https://www.clinicalleader.com/doc/...ks-mindmed-advances-psychedelic-to-phase-0001 Good excerpt from this article: Functional unblinding (i.e., participants can guess their treatment assignment) is a concern for any clinical trials involving a psychiatry drug. If a participant believes — because of how they feel — that they are in the group receiving the drug being tested, they may be more likely to report a good outcome. Conversely, if they don’t feel any differently, they may conclude they are in the placebo group and report negatively about their experience. To minimize this bias, Barrow says MindMed used centralized raters (the person interviewing the patient) who were blinded not only to treatment assignment but to the visit number. When asked to guess which dosing group a patient was in, often the raters were incorrect. For example, a third of the patients who got the placebo believed they had received the active drug. Around 85% of the patients who received the 25 micrograms dose correctly guessed that they were on drug; they knew they were feeling something. Nearly 90% of the patients who received the 50 micrograms dose could accurately guess they were on the drug, but they were the worst performing in terms of anxiety symptoms. The 100- and 200-microgram doses had the most robust responses, but patients on the 200-microgram dose had more adverse events (i.e., nausea, vomiting). “One interesting point about the study is that the 50 and 25 micrograms doses serve as kind of additional controls [as compared to just a placebo],” Barrow says. “I think it is as strong of a controlled study as you could possibly ask for. Observationally and clinically, it was very clear that 100 micrograms is the dose to take forward into our Phase 3 trial”
Here is a detailed comparison of the MindMed presentations from December 2024 and January 2025, focusing on updates and new content across various areas: 1. Financial Updates December 2024: Reports $295.3 million in cash and cash equivalents as of September 30, 2024, with a runway expected to fund operations into 2027 based on the existing operating plan. January 2025: Maintains the cash runway projection but now incorporates a $250 million equity investment, emphasizing financial support for clinical trials and commercialization. It also suggests the cash runway extends 12 months beyond the first Phase 3 topline data readout for MM120. 2. Pipeline and Clinical Trial Milestones Pipeline Progress Both Versions: Focus on MM120 (Lysergide D-tartrate) for GAD and MDD, with MM402 (R(-)-MDMA) targeting Autism Spectrum Disorder (ASD). January 2025: More detailed pipeline timelines: MM120-310 (MDD Phase 3): Initiated, with the first readout expected in 2H2025. MM120-300 and MM120-301 (GAD Phase 3): 300 initiated in late 2024, with readouts for both planned across 2025–2026. Clearer distinction in trial stages for MM120’s indications. Milestones December 2024: Mentions initiation of MM120 Phase 3 trials for GAD and regulatory alignment with the FDA after a successful end-of-Phase 2 meeting. January 2025: Adds milestones such as: Breakthrough Therapy Designation granted by the FDA for MM120. Innovation Passport awarded by the U.K.’s MHRA for faster regulatory review. Successful presentation of MM120 Phase 2b data at the American Psychiatric Association (APA) Annual Meeting. 3. Clinical Trial Designs and Outcomes Phase 3 Trial Designs December 2024: Provides general descriptions of trial phases, endpoints, and designs for GAD and MDD. Details inclusion criteria for trials, such as HAM-A ≥20 for GAD and MADRS ≥26 for MDD. January 2025: Expands on trial design with updates: GAD Phase 3 (MM120-300 & MM120-301): Increased participant count: MM120-301 now 250 participants (2:1:2 randomization) vs. earlier 200 participants. Adaptive design clarified for re-estimation of sample size based on interim results. MDD Phase 3 (MM120-310): Maintains 140 participants but emphasizes biweekly assessments and follow-ups for sustained efficacy monitoring. Phase 2b Results Both Versions: Highlight statistically significant results for MM120 in GAD: HAM-A reduction: -21.9 points vs. placebo (p=0.003). 48% remission rate and effect size d=0.81, over double the standard of care. January 2025: Provides deeper data visualization for: Remission and response rates (e.g., 65% response rate vs. 31% for placebo at 100 µg dose). HAM-A severity progression from baseline through Week 12, showing most participants achieving remission. 4. Regulatory and Strategic Developments Regulatory Updates December 2024: Mentions general alignment with FDA guidance and adherence to 2023 Draft Guidance for Psychedelic Drug Trials. January 2025: Elaborates on regulatory achievements: Breakthrough Therapy Designation for MM120 in GAD. Patents granted for MM120 covering formulation, manufacturing, and treatment methods, with protection through 2041. Strategic Focus January 2025: Emphasizes a pre-launch strategy for MM120, aiming to streamline commercialization through: Partnerships with interventional psychiatry clinics. Targeted stakeholder education on the unmet needs in GAD and MDD. Alignment with existing reimbursement frameworks. 5. Commercialization Framework January 2025: Introduces a bold strategy for integrating MM120 into clinical practice, leveraging: The Spravato (esketamine) delivery infrastructure with over 4,500 certified centers. Proven reimbursement pathways for medical and pharmacy benefits. Highlights the quadruple aim: 1. Better patient outcomes. 2. Improved clinician satisfaction. 3. Enhanced patient experiences (e.g., reduced clinical burden). 4. Lower healthcare costs due to early intervention. 6. Messaging and Presentation Enhancements December 2024: Focused primarily on clinical and operational updates. Limited emphasis on commercial value and stakeholder engagement. January 2025: Refined messaging to highlight MM120’s value proposition: Describes MM120 as a transformational innovation for brain health, shifting treatment paradigms from chronic symptom suppression to rapid and durable improvement. Enhanced graphics and layout for better communication of key clinical outcomes and strategic milestones. Summary of Key Additions in January 2025 New financial backing ($250M equity investment). Enhanced regulatory and patent achievements. More detailed trial designs and updates to participant frameworks. Comprehensive commercialization strategy tied to existing infrastructure. Stronger messaging on MM120’s transformative potential and alignment with evolving psychiatric treatment trends. Link to January 2025 Presentation - https://d1io3yog0oux5.cloudfront.ne...ndMed+January+2025+Corporate+Presentation.pdf Links to December 2025 Presentation - https://docs.publicnow.com/viewDoc?..._51CCCCDA60B64C1065AEB09DA309238E1625DA7D.PDF Reminder the presentations on MindMed will be replaced and old version links will not work when they have updated to a new one.
LD-2 Disclosure Form - MindMed Lobbying on Health & Wellness issues in DC https://lda.senate.gov/filings/public/filing/4f57d36b-4f51-4aee-9b72-f5f6e799019b/print/
