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Two separate deals hit the wires on Tuesday. One is PharmAla Biotech's (OTC:MDXXF) with Numinus Wellness (OTC:NUMIF) for a group therapy model with MDMA, the other is Optimi Health's (OTCQX:OPTHF) with Tel Aviv University for MDMA’s potential effects on addiction treatment.
PharmAla Biotech Holdings, a biotech company researching, developing and manufacturing proprietary MDMA "LaNeo" and new MDMA derivatives (aka MDXX-class molecules) entered into a binding sales agreement with Numinus Wellness to provide its GMP MDMA LaNeo for a prospective clinical trial, now holding for approval.
PharmAla's CEO and founder Nick Kadysh says the company is looking forward to supporting their new partners in their efforts, adding that LaNeo "is undoubtedly the drug product of choice for MDMA clinical trial practitioners in Canada and around the world" and "increasingly, for prescribers as well."
The research to be performed by Numinus aims to examine the feasibility of a group model in MDMA-assisted psychotherapy enrolling trainee practitioners as participants. The trial would allow Numinus to study MDMA-assisted psychotherapy with groups and "better understand the optimum number of therapists required to deliver the programs safely," as well as provide eligible trainees with the opportunity to build core competencies and legally experience MDMA.
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The biotech company announced it submitted the clinical trial application to Health Canada, the country's regulatory authority, on March 20. Formally titled “Phase 1 Exploration of Feasibility and Optimal Therapist Numbers in Group Model MDMA-Assisted Psychotherapy: A Study on Safety, Delivery, and Practitioner Training,” if approved, it will be the first of its kind.
“As research into MDMA’s efficacy in addressing serious mental conditions is increasing, it is particularly important that practitioners advance their knowledge of optimum delivery in a clinical setting. Our goal in designing this study is to explore the feasibility of a group model and take steps to help establish best practices in group-based therapy for MDMA and contribute to the body of evidence of its safety,” said Numinus CEO and founder Payton Nyquvest.
Rick Doblin, MAPS' founder and a volunteer strategic advisor to Numinus, added that the study "has the potential to significantly enhance patient outcomes by providing a means for practitioners to gain valuable insights.”
Optimi Health Corp., a Health Canada-licensed psychedelics pharmaceutical manufacturer, has entered an MDMA supply agreement with The Institute for Psychedelic Research at Tel Aviv University (IPR-TLV), marking the company’s first venture into the Israeli market.
Optimi's MDMA was made from in-house produced active pharmaceutical ingredients (API) and aims to support the institute’s research on the effects of MDMA on animal models of alcohol addiction. To date, Optimi has received a permit from IPR-TLV and is in the process of obtaining its export permit from Health Canada.
Expected to begin in the summer of 2024 and conclude in late 2025, the Optimi team says the study "aligns with their commitment to supplying MDMA to international researchers advancing mental health and addictions research," and predicts the study outcomes "will contribute to the academic discourse surrounding the therapeutic potential of MDMA."
Optimi CEO Bill Ciprick said the agreement with IPR-TLV "signifies an exciting entry into the Israeli psychedelics research market for Optimi" and reinforces the company's dedication to being at the forefront of the global psychedelic medicine landscape.
IPR-TLV's project aims to advance interdisciplinary research on psychedelics through brain-mind-body associations. Reportedly the first institute of its kind in Israel, it aspires to establish itself as a global leader in the neuroscientific investigation of psychedelics and psychoactive medicine.
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