The MAPS-sponsored multi-site study will be the first of its kind assessing the viability of MDMA-assisted therapy to treat eating disorders, including Anorexia Nervosa and Binge Eating Disorder.
TORONTO, Jan. 07, 2021 (GLOBE NEWSWIRE) — Field Trip Health Ltd. (CSE: FTRP) (OTCBB: FTRPF) (“Field Trip”), a leader in the development and delivery of psychedelic therapies, is pleased to announce it has, subject to completion of a final site inspection, been selected as a trial location for a MAPS-sponsored study on the safety, feasibility and preliminary outcomes of MDMA-assisted therapy to treat eating disorders (the “Eating Disorder Study”), including Anorexia Nervosa.
Anorexia Nervosa is a mental health condition and eating disorder characterized by low weight, food restriction, fear of gaining weight and a strong desire to be thin. Anorexia is also the most deadly mental illness, with a higher mortality (death) rate than any other mental illness, leading to potential cardiac complications, heart, kidney and liver failure, bone loss, anemia and suicide.
Subject to the site inspection, Field Trip’s Toronto location will be used as the trial site for the Health Canada-approved Anorexia Nervosa arm of the Eating Disorder Study. Field Trip’s Canadian Medical Director, Dr. Michael Verbora, will act as the Qualified Investigator and Site Physician for this site. During the Anorexia arm of the Study, Field Trip will be hosting MAPS-trained therapists who will be providing MDMA-assisted therapy to an initial cohort of individuals suffering from Anorexia Nervosa, and collecting safety, feasibility and preliminary outcome data.
In December, MAPS announced partial results of its first Phase 3 randomized, double-blind, placebo-controlled study assessing the safety and efficacy of MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD). According to MAPS, the study generated statistically significant results demonstrating that MDMA-assisted therapy may be an effective treatment for PTSD resulting from various types of trauma, including trauma occurring in childhood and in patients with dissociative subtype of PTSD, pending assessment by the U.S. Food and Drug Administration (FDA). Further, no unexpected or serious safety signals emerged during the course of the trial.
Field Trip Announces Annual Contribution to MAPS, Matching Contribution from Founders
Field Trip also announced today that it is becoming a financial supporter of MAPS, committing to making an annual contribution of $50,000 to MAPS, a 501(c)(3) non-profit organization in the United States, which will be matched by a collective contribution from the founders of Field Trip on a dollar-for-dollar basis. Site selection is conducted independently by MAPS Public Benefit Corporation and is unaffected by charitable contributions to MAPS.
“MAPS, led by Rick Doblin’s unique vision and relentless determination, has been at the forefront of the renaissance of psychedelics, pushing for scientific, regulatory and legal change for psychedelics for more than 30 years,” said Ronan Levy, Field Trip’s Executive Chairman. “The success of the Phase 3 PTSD trial is a pivotal achievement for MAPS, and a significant step forward for all people suffering from mental health conditions. We are pleased to be able to financially support MAPS both as an organization and individually, and we are honored to be conducting the critical work necessary to extend the reach of MDMA-assisted therapies to new indications such as Anorexia Nervosa.”
“For-profit or non-profit, we are all together in seeking to bring new methods of psychedelic healing to those millions who need it,” said Rick Doblin, MAPS’ Founder and Executive Director. “We greatly appreciate the generous support from Field Trip and its founders, and look forward to working with them as part of the Eating Disorder Study and beyond. One of MAPS’ principles is that we don’t have competitors, just allies in the larger mission of contributing to mass mental health.”
The safety and efficacy of MDMA-assisted therapy are currently under investigation. It has not yet been approved by Health Canada or the FDA for any mental health condition, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future Health Canada or 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 projections.
About Field Trip Health Ltd.
Field Trip is a global leader in the development and delivery of psychedelic therapies. With our Field Trip Discovery division leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics including psilocybin-producing fungi and our Field Trip Health division building centers for psychedelic therapies opening across North America and Europe along with the digital and technological tools that will enable massive scale, we help people, from those in treatment to those seeking accelerated personal growth, with a simple, evidence-based way to heal and heighten engagement with the world.
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For further information, contact Ronan Levy, Executive Chairman and a Director at Field Trip, at 1 (833) 833-1967.
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. Since its founding, MAPS has raised over $100 million for psychedelic therapy and medical marijuana research and education.
ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization
Cautionary Note Regarding Forward-Looking Information.
This release includes forward-looking information within the meaning of Canadian securities laws regarding Field Trip and its business, which may include, but are not limited to, statements with respect to the listing of the common shares of Field Trip on the Canadian Securities Exchange, and the timing of such events. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such statements are based on the current expectations and views of future events of the management of Field Trip, and are based on assumptions and subject to risks and uncertainties. Although the management of Field Trip believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including risks regarding the COVID-19 epidemic, the medical clinic industry, market conditions, economic factors, management’s ability to manage and to operate the business and the equity markets generally. Although Field Trip has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Field Trip does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
The CSE has neither approved nor disapproved the contents of this news release.
KCSA Strategic Communications
SOURCE Field Trip Health Ltd.