Wesana Health Commits Funding of $1.5 Million To Support MAPS’ Research Pipeline
MAPS to Investigate Viability of Research Pathway for MDMA-Assisted Therapy to Treat Traumatic Brain Injury
Effort Positions MAPS, Sponsor of the Only Completed Phase 3 Trial for Psychedelic-Assisted Therapy, to Serve New Unique Role Within
Wesana Health Holdings Inc. (CNSX: WESA; OTCMKTS: WSNAF), an emerging data-driven life sciences company focused on developing innovative approaches for better understanding, protecting and improving neurological health and performance, including through the advancement of psychedelic medicines, announced its commitment to fund an initial US $1.5 million to assess the viability of Multidisciplinary Association for Psychedelic Studies (MAPS) MDMA-assisted therapy to treat traumatic brain injury (TBI).
Under the terms of the recently signed memorandum of understanding, Wesana’s financial commitment will enable MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), to activate a team to evaluate the scope of unmet need for TBI treatment and help to define terms of a desired joint venture between MAPS and Wesana. Use of funds will include, in part, legal support in drafting and finalizing a partnership agreement, business development and executive staff costs in evaluating viability of the treatment, and other research-related expenses including establishing ethical guidelines governing the desired agreement.
MAPS’ research has primarily focused on MDMA-assisted therapy for PTSD, with the first of two Phase 3 trials demonstrating a clinically significant reduction in PTSD symptoms for 88% of participants. Similar to PTSD, TBI can have profound, diverse, and life-long impacts on a person’s physical and mental health. Lingering visible and invisible challenges interfere with work, education, and relationships, with disproportionate impacts for people of color. While leading front-line treatments are considered effective for some individuals or types of injury, more than 6.2 million Americans are estimated to have chronic TBI-related disabilities and millions more live with milder, yet disruptive, symptoms. Nearly 414,000 Iraq and Afghanistan Veterans had a TBI and for many, long-term negative health outcomes are poorly understood.
“Wesana is a serious, thoughtful and ethical company engaged in the development of psychedelic-assisted therapy. What Daniel and his team are doing is in line with MAPS’ ethics, mission, values and scientific rigor, and we believe together, MAPS and Wesana can bring much needed help to the massively underserved TBI population. Data collected from MAPS-sponsored Phase 3 clinical trials suggests that MDMA-assisted therapy appears promising in the treatment of TBI. Consistent with our mission, we seek to investigate treatments for affected patients who can be helped by MDMA – this is an important step in that direction” said MAPS Executive Director Rick Doblin, Ph.D.
The work MAPS has done for more than 35 years with regulators and clinical researchers to navigate the rigorous and necessary FDA approval process for MDMA therapeutic use has positioned psychedelic-assisted therapy on the precipice of national – and global – acceptance. The millions of people afflicted with PTSD may soon have access to MDMA therapy, and we believe the millions suffering from TBI may experience similar relief in the future.Daniel Carcillo, CEO of Wesana Health
This first-of-its-kind research collaboration between MAPS and Wesana will accelerate MAPS PBC’s research timelines and provide additional support for further research, advocacy, education, and equitable access to MDMA-assisted therapy treatments. Under the terms of the relationship, Wesana is expected to:
- Gain expertise and information to design psychedelic-assisted therapy programs for TBI and improve the Wesana timeline and path to market for its treatments
- Explore obtaining an exclusive commercial license to use MDMA for the treatment of TBI
- Evaluate the viability of revenue share agreements between the organizations
- Adapt MAPS’ equitable access research projects to develop a meaningful patient access program
- Fund associated research, administered by MAPS PBC, with additional capital
Carcillo continued, “Success in forming a research collaboration with MAPS is expected to shrink Wesana Health’s time to market for MDMA therapy for TBI to a handful of years. With millions of people around the world experiencing injuries impacting their brain health, our hope is that through this partnership we will soon deliver meaningful help to the victims, families, friends and communities affected by TBI.”
The safety and efficacy of MDMA-assisted therapy is currently under investigation. It has not yet been approved by the FDA, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future FDA approval or availability of MDMA-assisted therapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from our projections.
The formation of a long-term partnership between Wesana and MAPs remains subject to, among other things, negotiation and execution of definitive documentation and satisfaction of the conditions precedent negotiated therein. There is no assurance that any such definitive documentation will be settled and entered into by the parties nor that any such conditions precedent will be met.
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