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
CHICAGO, Sept. 14, 2021 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc. (“Wesana” or the “Company”) (CSE: WESA; OTCQB: 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.
Daniel Carcillo, CEO of Wesana Health added “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.”
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.
Wesana is an emerging life sciences company championing the development and delivery of psychedelic and naturally-sourced therapies to treat traumatic brain injury (TBI) and other neurological conditions. Through extensive clinical research and academic partnerships, Wesana is developing evidence-based formulations and protocols that empower patients to overcome neurological, psychological and mental health ailments caused by trauma.
Learn more at www.wesanahealth.com
Forward-Looking Information and Statements
This news release contains “forward-looking information” within the meaning of applicable securities laws with respect to the Company and MAPs, including, but not limited to: information concerning the completion and timing of completion of the initial US$1.5 million funding to MAPs, information concerning the completion and timing of entering into a partnership with MAPs, expectations regarding whether the contemplated partnership will be consummated, including whether conditions to the consummation of the partnership will be satisfied, expectations for the effects of the contemplated partnership on the business of the Company, expectations regarding the markets to be entered into by the Company as a result of the contemplated partnership, the ability of the Company to successfully achieve its business objectives as a result of entering into the contemplated partnership, expectations regarding the method by which future revenue is generated, expectations regarding the safety and efficacy of MDMA-assisted therapy, including therapies that are being developed by MAPs, and any other statement that may predict, forecast, indicate or imply future plans, intentions, levels of activity, results, financial position, operational or financial performance or achievements. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “will”, “projects”, or “believes” or variations (including negative variations) of such words and phrases, or statements that certain actions, events, results or conditions “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Except for statements of historical fact, information contained herein constitutes forward-looking information.
Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management at the date the statements are made including among other things assumptions about the ability of the Company to successfully negotiate and enter into definitive documentation in respect of the contemplated partnership with MAPs and satisfy any related conditions precedent; the ability of the Company to raise sufficient capital to advance the business of the Company, including to be able to fund such partnership with MAPs; development costs remaining consistent with budgets; favorable equity and debt capital markets; favorable operating conditions; obtaining and maintaining all required licenses and permits; receipt of governmental approvals and permits; political and regulatory stability; the level of demand for the Company’s proposed products and services; the ability of the Company to be successful in its research and development initiatives; and the availability of third party service providers and other inputs for the Company’s operations. While the Company considers these assumptions to be reasonable, the assumptions are inherently subject to significant business, social, economic, political, regulatory, competitive and other risks and uncertainties, contingencies and other factors that could cause actual performance, achievements, actions, events, results or conditions to be materially different from those projected in the forward-looking information. Many assumptions are based on factors and events that are not within the control of the Company and there is no assurance they will prove to be correct.
Furthermore, such forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual plans, intentions, activities, results, financial position, performance or achievements of the Company to be materially different from any future plans, intentions, activities, results, financial position, performance or achievements expressed or implied by such forward-looking information. Such factors include, among others: the inability of the Company to successfully negotiate and enter into definitive documentation in respect of the contemplated partnership with MAPs and satisfy any related conditions precedent; the inability of the Company to raise sufficient capital to advance the business of the Company, including to be able to fund such partnership with MAPs; and such other risks factors discussed in the Company’s annual information form dated September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and in the Company’s other public filings available on SEDAR. Although the Company has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such forward-looking information will prove to be accurate as actual results and future events could differ materially from those anticipated in such information. Accordingly, readers should not place undue reliance on forward-looking information. Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.