Last Thursday, MAPS Public Benefits Corporation published results from its Phase 3b trial utilizing MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. The New York Times ran a featured article on the clinical trial results, noting the following:
"During the experimental sessions, 53 participants were given MDMA and 51 were given an inactive placebo. Neither the therapists nor the participants were informed which patients had received the MDMA.
The participants in the group that were given MDMA experienced significantly greater reductions in their PTSD symptoms compared with those in the group that were given a placebo, according to the research article.
By the end of the study, 86.5 percent of people in the MDMA group achieved a measurable reduction in severity of symptoms, researchers reported. About 71 percent in the MDMA group improved enough that they no longer met the criteria for a PTSD diagnosis. Of those who took the placebo, 69 percent improved and nearly 48 percent no longer qualified for a PTSD diagnosis."
The results are compelling and it seems likely that MDMA is heading for full FDA approval for the treatment of PTSD in the first half of 2024. Other medical psychedelics could follow in 2025 and 2026. Cybin (NYSE:CYBN) and MindMed (Nasdaq:MNMD) are targeting major depressive disorder (MDD) with psilocybin and LSD respectively.
On August 17th, Cybin announced that it has initiated preparations for good manufacturing practices (GMP) production of a capsule formulation of CYB003, its proprietary deuterated psilocybin analog in development for the potential treatment of Major Depressive Disorder (MDD).
In its current Phase 2 MDD study, CYB003 dosing is underway in the final cohort. Topline efficacy data is expected in Q3/Q4 of 2023, after which the Company intends to submit data to the U.S. Food and Drug Administration (FDA) for an end of Phase 2 meeting. Shipments of CYB003 capsules to clinical sites are expected in Q1 2024, in anticipation of a potential phase 3 trial.
Meanwhile MindMed is advancing its MM-120 LSD D-tartrate through multiple clinical trials simultaneously. MM-120 is a potent serotonin agonist with potential applications to a broad range of brain health disorders.
Last week, MindMed announced that it has completed enrollment and dosing in Study MMED008, the Company’s Phase 2b study evaluating MM-120 (lysergide D-tartrate) for the treatment of GAD.
MindMed is also investigating MM-120 in the treatment of Major Depressive Disorder, and ADHD.
Finally, MindMed plans to initiate its first clinical trial of MM-402 (also referred to as R(-)-MDMA) in Q4 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.
Last week hedge billionaire Steve Cohen's flagship fund, Point72 (which boasts over $26 billion in assets), disclosed in a new filing that it has purchased 18.95 million shares of Cybin. This position represents an 8.1% stake in the Company:
It is especially notable that Steve Cohen has been one of the largest donors to psychedelic research through his family foundation. He has been one of the largest charitable backers of the MAPS clinical trial for MDMA. Furthermore, Steve Cohen is a highly successful biotech investor and has been very active in companies developing new therapeutic drugs and compounds.
This is the first example that I can think of in which a major hedge fund has taken a significant stake in a publicly traded medical psychedelics company. It could signal a new chapter has begun for this nascent sector, a potentially much more rewarding one for investors.
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