PharmAla Begins Groundbreaking Observational Trial for Real-World Efficacy of MDMA Therapy

On November 9, 2023, a progressive initiative to evaluate the real-world effectiveness of MDMA-assisted therapy was announced jointly by PharmAla Biotech Holdings Inc. (PMBHF), the University of Calgary (UC), and Heroic Hearts Canada (HHC). This collaboration is set to launch the first observational trial of its kind, focusing attention on the therapeutic potential of MDMA in treating patients with PTSD.

The trial follows the completion of a Letter of Intent (LOI) and initial ethics board approval, with a unique multi-party partnership at its core. PharmAla, the sole manufacturer of clinical-grade GMP MDMA in Canada, will supply the drug to physicians under Health Canada's Special Access Program (SAP) and will be responsible for linking clinicians, as well as patients, to UC researchers for voluntary data collection.

Driving the scientific analysis, the University of Calgary, guided by Dr. Leah Mayo, will meticulously evaluate the collected data to determine the real-world efficacy of MDMA therapy in PTSD cases. In support of advancing therapeutic methods, HHC extends its assistance by providing participants in their program the opportunity to add to the Real World Evidence (RWE) by joining the trial.

RWE gathered throughout the study will be invaluable, potentially influencing the decisions of health regulators, including Health Canada and Veterans Affairs Canada, on future treatment standards. Moreover, the trial has received strong support thanks to a recent urging from the Senate of Canada’s Subcommittee on Veterans for more research into psychedelic therapies for veterans' mental health challenges.

As the trial is observational in nature, it will not involve administering doses as part of the protocol, but rather focus on collating data pertaining to patients already cleared for SAP treatments. Such evidence collection will be beneficial for regulatory submission and for bolstering the scientific understanding of MDMA-assisted therapy’s effectiveness and safety.

PharmAla's CEO, Nick Kadysh, has declared their collaboration a significant stride towards concrete evidence of MDMA as a viable treatment option. Dr. Mayo considers the trial a pioneering assessment of MDMA's value outside the constraints of controlled clinical trials. HHC’s Executive Director, David Fascinato, highlights the partnership’s pivotal role in paving the way for accessible, approved psychedelic-assisted therapies to veterans and potentially a wider demography in need.

Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accept responsibility for the adequacy or accuracy of the release. Forward-looking information within the press release aims to outline PharmAla's strategic direction, influenced by current beliefs and assumptions subject to risks and uncertainties that could cause actual results to differ materially.

PharmAla, MDMA, Trial, Observational, PTSD, Therapy, Real-World, Efficacy, HeroicHearts, UCalgary, Veterans, HealthCanada, Research, Psychedelic, Treatment, SAP