At the moment, about 14 million people live with PTSD just in the U.S. Unfortunately, despite extensive clinical research, PTSD is still a significant unmet medical need. However, that may soon change with the US FDA’s acceptance of a New Drug Application from Lykos Therapeutics for MDMA (midomafetamine). Even better, the company’s “study found that MDMA induced significant and robust attenuation in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5,” as noted by DrugTopics.com. This development not only marks a significant leap in mental health treatment but also holds profound implications for companies like Numinus Wellness Inc. (TSX: NUMI) (OTC: NUMIF), Compass Pathways (NASDAQ: CMPS), Seelos Therapeutics (NASDAQ: SEEL), atai Life Sciences (NASDAQ: ATAI), and Mind Medicine (NASDAQ: MNMD) (NEO: MMED).
In addition, “Securing priority review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD," Amy Emerson, chief executive officer of Lykos, said in a release. "We remain focused on working with the FDA through the review process and preparing for a controlled launch with an emphasis on quality should this potential treatment be approved."
Also, according to Numinus Wellness, “The FDA's early acknowledgment of the potential benefits of MDMA-assisted therapy provides a significant boost to the legitimacy of psychedelic therapies. This is good news that we anticipate will pave the way for broader acceptance and integration of these treatments into mainstream mental healthcare.”
US FDA Action Also a Strong Catalyst for Numinus Wellness Inc. (TSX: NUMI) (OTC: NUMIF)
Numinus Wellness Inc., a mental health care company advancing traditional and innovative behavioral health treatments with a focus on safe, evidence-based psychedelic-assisted therapies, congratulates the Multidisciplinary Association for Psychedelic Studies for incubating the research that led to the first new drug application to the USFDA, submitted by Lykos Therapeutics (formerly MAPS Public Benefit Corporation) on the acceptance of its new drug application to the U.S. Food and Drug Administration for MDMA (midomafetamine capsules) used in combination with psychological intervention for individuals with PTSD.
The FDA has granted the application a priority review, which mandates the authority to take action within six months. A Prescription Drug User Fee Act target action date of August 11, 2024, has been set.
“This is an exciting development and, if approved, would be the first MDMA-assisted therapy available in the U.S. for the millions of Americans struggling with PTSD,” said Payton Nyquvest, Numinus Founder and CEO. “Getting here was the result of over 20 years of clinical research that was begun by MAPS, the nonprofit organization that founded Lykos, and we are proud to have collaborated with them through participation in the clinical research at our Cedar Clinical Research facilities. There needs to be a dedicated focus on building the infrastructure to be able to administer MDMA-AT if the FDA approves. Numinus has been at the forefront of this effort through training and offering services that are sustainable and scalable while ensuring the highest quality outcomes for clients. We look forward to actively supporting these efforts in the immediate future to continue to help meet the needs of over the 14 million people diagnosed with PTSD in the United States.”
“Psychotherapy is a component of the proposed treatment, and with our clinic network, practitioner training program and protocols we have developed in conjunction with our clinical research programs, we would like to be able to offer MDMA-assisted therapy as soon as regulators allow,” added Michael Tan, President and COO of Numinus. “It’s important to note that in our Canadian clinics, we are currently treating patients with MDMA-assisted therapy on a limited scope under the current regulatory exceptions. The combination of our experience and infrastructure positions us to be a leading provider of psychedelic-assisted therapy.”
Strategic Advisor
Numinus further proudly announced that Rick Doblin, Ph.D., the Founder and President of MAPS, is independently joining as an unpaid, non-exclusive strategic adviser of Numinus to help guide enhancements to and foster empirical validation of Numinus treatment modalities and training assets related to MDMA-assisted therapy. Numinus and Dr. Doblin share a common goal of ensuring broad access to treatment, focusing on inclusivity and making quality care accessible to all those seeking transformative therapeutic treatments. This appointment fortifies the company’s commitment to training programs which support the efficacy and safety of MDMA-assisted therapy for PTSD.
"We are honored to welcome Dr. Rick Doblin to Numinus as an unpaid strategic adviser. His wealth of experience and commitment to the advancement of psychedelic-assisted therapies align seamlessly with Numinus' mission to provide transformative and accessible care to individuals worldwide," said Payton Nyquvest.
"My hope in becoming an unpaid, non-exclusive Numinus Strategic Advisor is to accelerate our collective mission to expand access to psychedelic-assisted therapies. I look forward to contributing to the evolution of MDMA-related training and care programs, ultimately advancing the standard of care in this transformative field." expressed Dr. Rick Doblin.
Other related developments from around the markets include:
Compass Pathways, a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, and Hackensack Meridian Health, a leading not-for-profit health care organization and the largest, most comprehensive and truly integrated network in New Jersey, announced that that they have entered into a research collaboration agreement to inform the delivery model design of investigational COMP360 psilocybin treatment, if FDA-approved. The collaboration between Compass and HMH aims to improve health outcomes and improve patient and provider experiences for mental health conditions such as treatment-resistant depression. Together they will work to understand the real-world challenges and opportunities of delivering care to those living with depression, to inform how future clinical trials of COMP360 psilocybin treatment are designed, and to understand how it will be delivered to patients, if approved. COMP360 is Compass’s investigational proprietary formulation of synthetic psilocybin, administered in conjunction with psychological support.
Seelos Therapeutics, a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced the receipt of minutes from its End of Phase II Meeting with the FDA. In the meeting minutes, the FDA agreed that the primary endpoint in a Phase III trial could be the change from baseline in the Montgomery-Åsberg Depression Rating Scale total score at Day 16, rather than the 24-hour timepoint that was selected in the Phase II SLS-002-201 study. The key secondary endpoint could be the change from baseline at 24 hours on the suicidality scale. This agreement with the FDA gives Seelos further confidence for its Phase III development of SLS-002 as data in the Phase II study showed clinically significant treatment differences from placebo on both the Day 16 MADRS and the 24-hour Sheehan- Suicidality Tracking Scale.
atai Life Sciences, a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced a strategic investment in Beckley Psytech Limited, a private clinical-stage biotechnology company dedicated to transforming short-duration psychedelics into effective and rapid-acting medicines for neuropsychiatric conditions. This strategic investment and collaboration aims to accelerate the development of Beckley Psytech’s two clinical-stage, patent-protected, short-duration psychedelic candidates, BPL-003 and ELE-101, by adding them to atai’s mental health innovation platform. BPL-003 is a novel, short-duration, intranasal formulation of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT also known as Mebufotenin), and ELE-101 is a novel intravenous formulation of psilocin, the primary moiety of psilocybin.
Mind Medicine provided a corporate update and outlook for 2024. "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, CEO 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."
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