Numinus Receives Approvals to Start Recruiting Participants in MAPS PBC Study

Numinus Wellness Inc. (TSX:NUMI) (OTC:NUMIF) is a Canadian company that helps heal people’s mental health through psychedelic-assisted therapies. The Numinus model is at the forefront of a transformation aimed at healing rather than managing the symptoms of depression, anxiety, trauma, pain and addiction.

In November, Numinus Wellness announced that it has secured two new Canadian psychedelic clinics that will host the Canadian sites for the MAPS Public Benefit Corporation (MAPS PBC) study “A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX).” The company has completed the steps necessary to begin recruiting participants in the study.

The study, which will continue to investigate the safety and efficacy of MDMA in the treatment of severe PTSD, led by MAPS PBC as study sponsor, recently received regulatory approval from Health Canada, Institutional Review Board (IRB) ethics approval and has received an exemption under Section 56 of the Controlled Drugs and Substances Act, which will allow the use of MDMA for the duration of the clinical trial.

“We are thrilled that our talented team of doctors and at Numinus are helping pave the path forward to greater access to safe and effective psychedelic-assisted psychotherapy with this study in determining how effective MDMA is in treating severe PTSD,” said Payton Nyquvest, Founder and CEO, Numinus.

Numinus Wellness Inc. (TSX:NUMI) (OTC:NUMIF) is hosting the Canadian sites for MAPPUSX, managed through two new specialty clinics in Montreal and Vancouver, enabling the rapid completion of the MAPS trial in Canada.

“The recent approvals from Health Canada and IRB, coupled with our clinics in Montreal and Vancouver already being regulatory compliant, allow us to quickly complete this phase of the research at these sites,” said Dr. Joe Flanders, VP, Psychology, Numinus and therapist for the Montreal site of the trial.

The trial will be open to eligible participants who were previously enrolled in the parent study’s placebo arm (MAPP1) or were unable to receive treatment due to COVID-19 restrictions.

Numinus Achieves Key Milestones

Numinus Wellness Inc. (TSX:NUMI) (OTC:NUMIF) announced on January 14 that it has officially submitted the Clinical Trial Application (CTA) to Health Canada for its Phase 1 study, HOPE, of a naturally occurring psilocybe extract formulation, NBIO-01. This important milestone advances and reinforces Numinus’ long-standing work in developing safe and effective psychedelic products from its Health Canada-accredited research facility, Numinus Bioscience. As Numinus’ first fully stand-alone clinical trial, HOPE is a two-phase study that will take place at a Numinus clinic in Vancouver. Upon approval, the company will begin testing the extract’s bioavailability and tolerability on 20 healthy volunteers, followed by testing against a psilocybin comparator on a further 28 healthy volunteers.

In December, Numinus commended Health Canada’s leadership for modifying the Special Access Program (SAP) to allow physicians to request patient access to psychedelic treatments, such as MDMA and psilocybin-assisted therapy, for serious conditions resistant to treatment or life-threatening, on a case-by-case basis. The amendment has the potential to positively impact the lives of people with serious mental health issues where other therapies have failed, are unsuitable or are unavailable in Canada.