Numinus CEO Expects MAPS Phase 3 MDMA-Assisted Therapy Readout To Galvanize The Sector
On this new Psychedelic Series Podcast, TDR Founder Shadd Dales spoke with Payton Nyquvest, CEO of Numinus Wellness Inc. (TSE: NUMI) (OTCMKTS: NUMIF). The podcast focused on the near term roadmap, specifically, MAPP2 Phase 3 clinical trial final readout, its impact to all beneficiaries involved, why the readout is a momentous event for the industry, and more.
With Numinus right-sizing its business to prepare for an increase in expected patient visitations, the industry is patiently waiting for MAPP2 final results. As Payton notes, it won’t simply be a confirmatory readout like previous results. The final report will include detailed information and new efficacy data that will either reaffirm earlier findings, or perhaps, diminish them. Payton expects the readout to occur any day—perhaps soon after Labor Day—although the timing is out of Multidisciplinary Association for Psychedelic Studies (MAPS) hands.
While MAPS and Numinus are the most immediate beneficiaries of robust data, Payton expects the rest of the sector will benefit. After all, the readout will mark the only fully complete Phase 3 clinical trial in the sector to date, leading to the first New Drug Filing Application for a psychedelic drug/therapy combo.
Should the data check out, this should give the industry its second major boost this month, following the 9-digit securities purchase agreement COMPASS Pathways was able to procure with a select group of healthcare-minded investors on August 16. Mr. Nyquvest expects additional institutional interest to be generated upon a favorable readout, especially with MAPS headed into the FDA funnel.
And although biotech progress moves slowly in the best of times, the approval and subsequent commercialization of MDMA-assisted therapy in not far away. At the June Psychedelic Science 2023 Conference hosted by MAPS, an official presentation indicated that MDMA-assisted therapy was on track for FDA approval by mid-2024, with commercialization advancing finishing by the end of 2024.
Of course, the bonds between Numinus and MAPS have long been established. In June, Numinus announced a partnership with MAPS last month that aims to provide practitioners with unique experiential opportunities as part of a clinical study focused on MDMA-assisted therapy. Under the proposed initiative, Numinus would offer exclusive experiential opportunities for practitioners involved in the clinical study, pending the approval of their Clinical Trial Application (CTA) by Health Canada.
Furthermore, Numinus and MAPS already have an existing working collaboration, with Numinus participating in MAPS multi-site, double-blind, placebo-controlled, randomized Phase 3 study which assessed the efficacy and safety of MDMA-assisted therapy versus therapy with placebo control in participants diagnosed with at least moderate PTSD.
Click on the embedded link to view TDR’s latest conversation with Numinus CEO, Payton Nyquvest, in his own words.
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