Last week, Numinus Wellness Inc. (TSX Venture: NUMI) (OTC: LKYSF) announced a major milestone and reported that Health Canada has approved the previously announced Multidisciplinary Association for Psychedelic Studies (MAPS)-sponsored safety and feasibility study that will evaluate a MDMA-assisted therapy for post-traumatic stress disorder (PTSD).
The study is a collaboration between Numinus and MAPS Public Benefit Corporation (MAPS PBC), which is a wholly owned subsidiary of MAPS and is considered to be the leading developer of MDMA-assisted therapy training programs, treatment protocols, and research.
During the last year, Numinus has reported a series of important developments and we are favorable on how the business has advanced. From forming strategic relationships with companies like MAPS to strengthening the balance sheet, the mental health care company is well positioned to record long-term growth.
Numinus is led by a management team that is laser focused on advancing innovative treatments and evidence-based psychedelic-assisted therapies. The collaboration with MAPS PBC is a real-world study which expands the access that Numinus has to MDMA-assisted therapy for patients with PTSD and concurrent disorders. The collaboration will provide data on a regulated model for an MDMA-assisted therapy, and we expect any advancement to be a catalyst for the entire cannabis sector.
The study will provide regulators with safety and outcome data to support the integration of an MDMA-assisted treatment in the mainstream mental health care market. The fact that Health Canada has issued a No Objection letter is significant and we expect to see increased interest in Numinus as a result.
This study has advanced through the pre-implementation stage at Numinus’ Vancouver clinic and has received the required federal regulatory approval. Study preparations are now transitioning into the final stages, and we are bullish on how the study is advancing. During the study, Numinus will collect data on the safety and effectiveness of an MDMA-assisted therapy to inform Health Canada and support making these types of therapies available to people who are suffering from PTSD in Canada.
A few months ago, MAPS announced results from a Phase 3 randomized clinical trial that confirmed the substantial efficacy and safety of its MDMA-assisted therapy for PTSD. The trial demonstrated that 88% of participants who received three controlled and supervised MDMA-assisted therapy sessions experienced a clinically significant reduction in symptoms, with 67% no longer qualifying for a PTSD diagnosis.
Through the collaboration and study activities, Numinus plans to create access for patients who suffer from PTSD and access the infrastructure that is required to scale up the access to an MDMA-assisted therapy.
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