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.
