MomsSpaghetti
5日前
Docket Number: FDA-2023-D-1987: Psychedelic Drugs: Considerations for Clinical Investigations; Draft Guidance for Industry; Availability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
Everyone should read this in full but here is the overview. Also, while this is older, I didn't uncover until now.
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MindMed appreciates the FDA's draft guidance on psychedelic drugs and supports the goal of facilitating their safe and effective development.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Draft Guidance Analysis: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.
MomsSpaghetti
3週前
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/press-releases/detail/167/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
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.
MomsSpaghetti
3週前
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.
MomsSpaghetti
4週前
MindMed Announces New Employee Inducement Grants
https://ir.mindmed.co/news-events/press-releases/detail/165/mindmed-announces-new-employee-inducement-grants
Dec 02, 2024 7:00 am EST
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 issuance of inducement grants to four newly hired non-executive employees consisting of options to purchase an aggregate of 171,000 common shares of the Company (the "Options"), with effective grant dates of November 18, 2024 and December 2, 2024, depending on the applicable employee’s respective start date. The Options have an exercise price equal to the closing price of MindMed’s common shares on the last trading day on which MindMed’s common shares traded prior to the date of the respective grant, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in substantially equal monthly increments over the three-year period thereafter, subject to each employee’s continued employment.
The Options were granted as a material inducement to each employee’s employment and were approved by MindMed's Compensation Committee on November 15, 2024, in accordance with Rule 5635(c)(4) of The NASDAQ Stock Market LLC. The Options were granted outside MindMed's equity incentive plans.
MomsSpaghetti
1月前
Good listen... let's remind our self's of one thing... because the episode title is garbage.
While lysergic acid diethylamide (LSD) itself is not patentable due to its long-standing existence, MindMed has developed MM-120, a proprietary, pharmaceutically optimized form of LSD. To protect their innovation, MindMed has secured patents on specific formulations and delivery methods of MM-120. Notably, in July 2024, the United States Patent and Trademark Office (USPTO) issued a patent covering the MM-120 Orally Disintegrating Tablet (ODT) formulation. This patent includes claims on the pharmaceutical formulation, manufacturing methods, and treatment methods for MM-120 ODT, extending MindMed’s intellectual property protection through 2041. ?
Additionally, MindMed holds exclusive rights to Catalent’s Zydis ODT fast-dissolve technology for all salt and polymorphic forms of lysergide (LSD) for pharmaceutical use in several regions, including the United States, the United Kingdom, the European Union, Switzerland, Israel, and Canada. ? This advanced formulation aims to offer rapid absorption, improved bioavailability, and reduced gastrointestinal side effects, potentially providing a unique clinical profile for MM-120.
By focusing on these proprietary formulations and delivery technologies, MindMed establishes a competitive advantage and safeguards its developments in the therapeutic application of LSD derivatives.
Having said that... we are moving into phase 3 and with lots of positive push from prior trials. The data proves there is something here. Risk mostly has been removed.
We are going to rebound. MindMed is a winner in this space. It's only a matter of time.
MomsSpaghetti
1月前
New Association Launches to Expand Patient Access to Psychedelic Medicines
https://www.prnewswire.com/news-releases/new-association-launches-to-expand-patient-access-to-psychedelic-medicines-302311365.html
News provided by
Association for Prescription Psychedelics
Nov 20, 2024, 06:56 ET
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Organization Will Educate Policymakers and Advocate for the Development of Safe and Effective Prescription Psychedelics
WASHINGTON, Nov. 20, 2024 /PRNewswire/ -- The Association for Prescription Psychedelics (APP) announced its launch today to integrate proven, efficacious, and evidence-based prescription psychedelic medicines into the health care system for eligible patients across the country.
APP will serve as a trusted and recognized voice on prescription psychedelics and highlight how government-sponsored research, public-private partnerships, patient centric treatment, and health care infrastructure investments can support this innovative area of medicine.
"There's a tremendous opportunity to address the unmet needs of patients across the country who are experiencing a wide range of health challenges by expanding access to psychedelic medicines," said Jon Kostas, Executive Director of APP and Chief Executive Officer of Apollo Pact. "The Association for Prescription Psychedelics will serve as the leading voice for clinical, evidence-based psychedelic medicines and treatments administered by licensed, experienced, and highly trained professionals in the medical community."
APP will be guided by prominent researchers and academics from the University of Alabama at Birmingham, Heffter Research Institute, University of Wisconsin, Shepard Pratt, Cleveland Clinic, Johns Hopkins University, and University of California San Francisco. The organization's founding members include B.More Inc., Compass Pathways, Lykos Therapeutics, and MindMed. APP's patient advocacy organization partners include Apollo Pact.
"Fostering strong collaboration between industry, academia, health care professionals, and policymakers can help advance scientific research into psychedelics and hopefully expand patient access to lasting and effective treatments," said Peter Hendricks, PhD, Professor and Heersink Endowed Chair of Psychiatry at the University of Alabama at Birmingham, who serves on as one of APP's scientific advisors. "Psychedelic research looks very promising for many treatment-resistant patients, and there is a good chance prescription psychedelic medicines will be a part of our healthcare system in the near future."
"As someone who credits psychedelic research with saving my life, I understand firsthand the life-changing effects of these treatments," added Kostas.
Visit psychedelicsRX.org to learn more.
About the Association for Prescription Psychedelics
The Association for Prescription Psychedelics (APP) works to educate and advocate for the development and accessibility of safe and effective prescription psychedelic medicines for patients. We serve as the trusted and recognized industry voice – at the national and state levels – on prescription psychedelic medicine and its integration into the healthcare system. Our education efforts help policymakers, regulators, and other key stakeholders learn about psychedelics and entactogens/empathogens and the associated medical conditions each compound may be able to treat. Our advocacy efforts help advance responsible legislative and regulatory policies that drive innovation, increase funding for research, and enhance access and coverage for prescription psychedelic medicine. Learn more at psychedelicsRX.org.
SOURCE Association for Prescription Psychedelics
MomsSpaghetti
1月前
MindMed Appoints Gregg Pratt, Ph.D. as Chief Regulatory and Quality Assurance Officer
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 Gregg A. Pratt, Ph.D., as Chief Regulatory and Quality Assurance Officer. Dr. Pratt will serve as a member of the Executive Committee and oversee the Company’s regulatory and quality functions, as well as its product registration strategies.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241118653031/en/
“We are thrilled to welcome Gregg to the MindMed team. His leadership will strengthen our capabilities and accelerate our progress as we prepare to launch three Phase 3 studies of MM120 orally disintegrating tablet (ODT) in generalized anxiety disorder (GAD) and major depressive disorder (MDD),” said Rob Barrow, Chief Executive Officer of MindMed. “Gregg’s deep expertise in leading the regulatory approvals of transformative psychiatric drugs—demonstrated by his recent leadership in the approval of the first novel schizophrenia treatment in decades—will be key as we advance our Phase 3 programs. His appointment also reflects our strong commitment to clinical and regulatory excellence as we aim for two potential approvals in the coming years and work to transform the treatment of brain health disorders.”
“The therapeutic potential of MM120 ODT, as demonstrated in the Phase 2b study results, inspired me to join MindMed in pursuing what could be one of the most meaningful breakthroughs in the field of psychiatry,” said Dr. Pratt. “With our Phase 3 trial initiations imminent, I am eager to collaborate with the team to ensure our regulatory approach supports continued execution of the Company’s strategy and, if approved, to deliver MM120 ODT as a novel, much-needed therapy for millions of patients living with GAD and MDD.”
Dr. Pratt brings more than three decades of experience in drug development, registration, and commercialization, with a distinguished career spanning multiple therapeutic areas including psychiatry, neurology, and cardiology. Dr. Pratt joins MindMed from Karuna Therapeutics, which Bristol Myers Squibb acquired in March 2024. At Karuna, he served as Senior Vice President of Regulatory Affairs and Quality Assurance, where he oversaw the regulatory submission and ultimate approval by the U.S. Food and Drug Administration of COBENFY™, the first product in four decades with a novel mechanism of action in schizophrenia. Before joining Karuna Therapeutics, Dr. Pratt held leadership positions at Lundbeck, Abbvie, Solvay, Collegium, Baxter, and Assertio Therapeutics, where he led regulatory affairs in drug, biologic, and combination product development strategies, as well as registration maintenance for approved products in global markets. Dr. Pratt has a Ph.D. in chemistry from West Virginia University and a Bachelor of Science degree from the University of Wyoming.
Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
In connection with his appointment as Chief Regulatory and Quality Assurance Officer, MindMed granted Dr. Pratt an inducement award consisting of an option to purchase an aggregate of 350,000 common shares of the Company (the "Option"), with an effective grant date of November 18, 2024. The Option has an exercise price equal to the closing price of MindMed’s common shares on November 15, 2024, the last trading day on which MindMed’s common shares traded prior to the date of the grant and will vest over a four-year period with 25% vesting on the first anniversary and the remaining 75% vesting in 36 equal monthly installments over the next three-year period thereafter, subject to his continued employment.
The inducement award to Dr. Pratt was granted as a material inducement to his employment and was approved by MindMed's Compensation Committee on August 31, 2024, in accordance with Rule 5635(c)(4) of The NASDAQ Stock Market LLC. The award was granted outside MindMed's equity incentive plans.
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. MindMed trades on NASDAQ under the symbol MNMD.
MomsSpaghetti
1月前
$MNMD - Institutional Ownership 74.64%
Active Positions
Holders Shares
Increased Positions
80
20,092,052
Decreased Positions
51
2,593,025
Held Positions
48
32,049,315
Total Institutional Shares
179
54,734,392
https://www.nasdaq.com/market-activity/stocks/mnmd/institutional-holdings
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