Numinus Wellness Inc (NUMIF)

[namah sivaya]

LKYSF news of trial with MAPS!

Numinus announces milestones in compassionate access trial for MDMA-assisted therapy in collaboration with MAPS Public Benefit Corporation


Trial enters pre-implementation stage having met several key milestones towards expanding access to patients with PTSD

VANCOUVER, BC, Feb. 18, 2021 /CNW/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSXV: NUMI), a company creating an ecosystem of health solutions centered around developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted psychotherapies, is pleased to share that the single-arm, open-label, compassionate access1 trial for MDMA-assisted therapy has made significant progress towards treating patients with posttraumatic stress disorder (PTSD). This trial is being pursued in collaboration with MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), the leading developer of the treatment protocols, research, and MDMA-assisted therapy training programs.

"We are excited to share an update on the progress of our MDMA compassionate access trial with the full recognition that existing therapies for PTSD are inadequate," said Payton Nyquvest, CEO of Numinus. "At Numinus, we are pleased to help foster a promising regulatory landscape that will contribute to a better understanding that psychedelic-assisted psychotherapies are a viable, safe, and necessary avenue for expanding existing treatment options. We look forward to continued collaboration with the Multidisciplinary Association of Psychedelics for Studies (MAPS PBC) and will work together to provide those experiencing PTSD with more treatment options."

This first-of-its-kind trial in Canada has advanced and successfully transitioned into the pre-implementation stage at Numinus' Vancouver clinic. This follows the successful completion of several milestones, starting with the recruitment of therapists, physicians, and staff in preparation for participant enrolment and the ultimate analysis of therapy outcomes. The highly qualified cohort of medical staff will be responsible for collecting safety data for Health Canada to further implement key research that supports individuals living with PTSD who have not benefited from existing treatment options.

In November 2020, eight Numinus therapists graduated from Part B of the MAPS MDMA therapist training program. Through their roles within the trial, they will complete the supervision requirement for certification as fully qualified MDMA therapists.

A draft MDMA-assisted therapy protocol for PTSD has been adapted for the trial, including clear guidance surrounding necessary screening processes, patient health histories, and indications and potential contraindications before accepting participants. Initial regulatory meetings with Health Canada to define the trial's implementation science strategy have been completed, and the next steps will include obtaining ethical and Health Canada approvals to allow the recruitment of participants according to COVID-19 public health protocols.

"Developing a skilled workforce is a key challenge for the safe delivery of psychedelic-assisted therapies, so we are pleased to engage with Numinus to train therapists in the MDMA-assisted therapy protocol for PTSD," said Amy Emerson, CEO of MAPS PBC.

Numinus is also pleased to announce that its Medical and Therapeutic Services Director, Dr. Devon Christie, will serve as both the trial's Principal Investigator and as a therapist. Dr. Christie is a family physician with a focus in multidisciplinary pain management, is a certified Relational Somatic Therapist, and is already MAPS-trained in the delivery of the MAPS MDMA-assisted therapy for PTSD.

"I am thrilled to be involved in a long-awaited clinical program that will help pave the way towards wider use of MDMA-assisted psychotherapy for those experiencing PTSD," said Dr. Christie. "The key milestones announced today are a true testament to our teams' commitment to establishing the physical, technical, clinical, and human resource infrastructure needed to swiftly move through the trial's formal implementation stages and ultimately towards the recruitment of the first participant."

https://www.newswire.ca/news-releases/numinus-announces-milestones-in-compassionate-access-trial-for-mdma-assisted-therapy-in-collaboration-with-maps-public-benefit-corporation-819950387.html