Numinus Wellness congratulates study team on announcement of results from Phase 3 randomized clinical trial of MDMA-assisted therapy for treatment of severe PTSD

Numinus Wellness Inc. (CVE:NUMI) has congratulated the Multidisciplinary Association for Psychedelic Studies (MAPS) and the MAPP1 trial study team for their announcement of results from the Phase 3 randomized clinical trial of MDMA-assisted therapy for the treatment of severe post-traumatic stress disorder (PTSD). The trial, which involved 90 participants with chronic PTSD, 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 PTSD diagnosis in comparison to 32% of participants randomized to placebo. Study participants had PTSD diagnoses from a range of causes, including combat-related events, accidents, abuse, sexual harm and developmental trauma.  READ: Numinus Wellness ends 2Q with C$28.5M after closing Mindspace Wellbeing acquisition The results, published in the peer-reviewed medical journal Nature Medicine, presented no serious safety concerns, and confirmed earlier findings from MAPS' six completed Phase 2 clinical trials that demonstrated clear safety and efficacy of MDMA-assisted therapy.  "These Phase 3 results confirm the substantial efficacy and safety of MDMA-assisted therapy for PTSD under the MAPS protocol," said Payton Nyquvest, chief executive officer of Numinus in a statement. "We hope this evidence encourages health regulators to urgently consider policy changes that broaden safe and evidence-based access not only to MDMA but other psychedelic-assisted therapies for mental health care."  Phase 3 is the final phase of research required by regulators, such as Health Canada and the US Food and Drug Administration (FDA), before deciding whether or not to approve MDMA as a legal prescription treatment for PTSD. Numinus and MAPS Public Benefit Corporation (PBC), a wholly-owned benefit subsidiary of MAPS, announced in December 2020 their collaboration on a compassionate access trial to deliver MDMA-assisted psychotherapy for PTSD for individuals with treatment-resistant PTSD who are unable to access MDMA-assisted therapy through a Phase 3 trial. Key milestones have since been announced, including the finalization of treatment protocols, training of trial therapists and appointment of lead investigators. The trial is currently in pre-implementation phase and will move into implementation in summer 2021. "Our compassionate access trial seeks to provide additional safety data to Health Canada that we expect will add to this impressive Phase 3 data to support eventual approval of MDMA-assisted psychotherapy for Canadians with PTSD," said Dr Devon Christie, Medical and Therapeutics Services Director of Numinus and Principal Investigator of the compassionate access trial by Numinus and MAPS. "The results highlight the importance of continued efforts such as those by Numinus to bring these treatments to the mainstream."  Millions are affected globally by PTSD. Canada showed the highest incidence of PTSD in a large-scale study of 24 countries that indicated 1 in 11 Canadians will suffer from PTSD in their lifetime. Current mental health treatments often present limited benefits, poor uptake and negative side effects while requiring chronic medication utilization. Psychedelic-assisted therapy is becoming more mainstream and increasingly accepted by US and Canadian regulators, and has been validated by academic and industry research. MDMA-assisted therapies for PTSD increasingly demonstrate efficacy, including one study showing higher safety and greater effectiveness compared to two common antidepressants and another study showing both substantial clinical impact and potential cost-savings of millions of dollars per year. Numinus Wellness empowers people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The company's model - including psychedelic production, research and clinic care - is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance abuse. Contact the author at jon.hopkins@proactiveinvestors.com