Numinus Congratulates MAPS on Phase 3 Clinical Trial Demonstrating Significant Benefits of MDMA-Assisted Therapy for Severe PTSD

Numinus and Multidisciplinary Association for Psychedelic Studies collaboration
will conduct follow-on Compassionate Access trial in real-world setting in Vancouver, Canada

Numinus Wellness Inc. ("Numinus" or the "Company") (TSXV: NUMI), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today congratulates 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 involved 90 participants with chronic PTSD. It 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.

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. "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 U.S. Food and Drug Administration (FDA), before deciding whether or not to approve MDMA as a legal prescription treatment for PTSD.

Bringing clinical results into a real-world context

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.¹ 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 antidepressants² and another study showing both substantial clinical impact and potential cost-savings of millions of dollars per year.³

Media, please note video content: Dr. Devon Christie provides her thoughts on the critical importance of the MAPS Phase 3 trial results , and further information on the upcoming Phase 2 compassionate access trial undertaken by Numinus and MAPS PBC in Canada.

1. Post–Traumatic Stress Disorder in Canada . CNS Neuroscience & therapeutics . 13 Aug 2008 .
2. Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline . Frontiers in Psychiatry. 12 Sep 2019 .
3. The cost-effectiveness of MDMA-assisted psychotherapy for the treatment of chronic, treatment-resistant PTSD . PLOS ONE. 14 Oct 2020 .

About Numinus

Numinus Wellness (TSX-V: NUMI) 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 Numinus Wellness 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. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice, and building the foundation for a healthier society.

Learn more at numinus.ca , and follow us on Facebook , Twitter , and Instagram .

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are "forward-looking statements". Forward-looking statements can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or statements that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licences and any inability to obtain all necessary governmental approvals, licences and permits to operate and expand the Company's facilities; regulatory or political change such as changes in applicable laws and regulations, including federal and provincial legalization of psychedelic therapies, due to inconsistent public opinion, perception of the medical-use of psychedelics, delays or inefficiencies or any other reasons; any other factors or developments which may hinder market growth; the Company's limited operating history and lack of historical profits; reliance on management; the Company's requirements for additional financing, and the effect of capital market conditions and other factors on capital availability; competition, including from more established or better financed competitors; the need to secure and maintain corporate alliances and partnerships, including with research and development institutions, customers and suppliers; the development and implementation of medical protocols and treatment standard operating procedures for the use of psychedelic therapies; the Company's goals to develop and implement partnerships with research organizations and other key players in the integrative mental health industry; the Company's ability to successfully withstand the economic impact of COVID-19; the medical benefits, safety, efficacy, dosing and social acceptance of psychedelics; the approval and/or success of compassionate access clinical trials; the cultivation and harvest of Psilocybe mushrooms; and the availability of trained personnel and medical professionals. These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company has no obligation to update any forward-looking statement, even if new information becomes available as a result of future events, new information or for any other reason except as required by law.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE Numinus Wellness Inc.

View original content to download multimedia: https://www.newswire.ca/en/releases/archive/May2021/10/c1224.html