IBS is a common, recurrent, and oftentimes debilitating affliction with an estimated prevalence of between 4-5%. Analytic studies have revealed that numerous patients suffering from IBS and their gastroenterologists are unsatisfied with the current treatments.
MGH and Tryp are collaborating to investigate the efficacy of psilocybin-assisted psychotherapy for individuals aged 21+ suffering from Irritable Bowel Syndrome (IBS). These participants have chronic abdominal pain, fibromyalgia, anxiety, fatigue and other debilitating digestive complications that stem from their condition.
Today, Tryp announced the successful completion of their Phase 2a clinical trial training for psychotherapists at Massachusetts General Hospital. This remarkable undertaking was spearheaded by Fluence, a leader in therapeutic guidance and psychedelic compounds administration, with renowned researchers and experienced therapists directly involved.
TRYP Therapeutics Completes Psychotherapy Training for Planned Phase 2a Clinical Trial at Massachusetts General Hospital
Kelowna Canada, (April 4, 2023) — Tryp Therapeutics, Inc. (CSE: TRYP) (OTCQB: TRYPF) (“Tryp” or the “Company”), a clinical-stage biotechnology company focused on developing intravenous-infused psilocin (the active metabolite of psilocybin) for diseases with high unmet medical needs, today announced it has completed the training of psychotherapists for its planned Phase 2a clinical trial investigating the effects of psilocybin-assisted psychotherapy in the treatment of patients aged 21+ suffering from Irritable Bowel Syndrome (IBS) at Massachusetts General Hospital (MGH). The training was conducted by Fluence, which is led by researchers and psychotherapists with direct experience in psychedelic clinical trials and is the foremost provider of psychotherapeutic training for health professionals that are administering psychedelic compounds to patients.
The planned study will evaluate the effect of psilocybin-assisted psychotherapy in patients with treatment resistant IBS who experience chronic abdominal pain and other debilitating gastrointestinal symptoms. Many of these patients also suffer from fibromyalgia, anxiety and fatigue. The primary efficacy endpoint of the study will be improvement in abdominal pain. The study will also explore changes in brain connectivity and responses to pain at baseline, four weeks, six months and twelve months, post-the psychedelic sessions, along with numerous other secondary endpoints.
Dr. Franklin King MD, Harvard Professor at the Center for the Neuroscience of Psychedelics, the principal investigator of the study, said, “Symptoms occurring at the mind-body interface, such as disorders of gut brain interaction, are often inadequately addressed by conventional psychological and somatic therapies alike. Given promising research suggesting that psychedelics bypass typical medical paradigms, we believe this is an extraordinarily promising avenue of research with significant potential benefit for patients.”
“The progress being made through our collaboration with Tryp Therapeutics shows there is potential for the treatment of debilitating IBS and other disorders of gut-brain interaction by utilizing the combined administration of psilocybin and psychotherapy,” added Dr. Erin Mauney, a physician at Massachusetts General Hospital leading the study. “We are pleased to have completed this training in advance of commencing the Phase 2a trial.”
Elizabeth Nielson, Ph.D., Co-Founder and Chief Visionary Officer of Fluence, commented “We’re thrilled to have the opportunity to work with Tryp Therapeutics and support their pioneering work in clinical research. It gives one confidence in the future of the field to see the high level of professionalism and care that’s gone into planning this study at Mass General Hospital. Studying psilocybin treatment for IBS, an indication that crosses the boundaries of gastroenterology and psychiatry, is a true innovation.”
In recognition of this important development, Jim Gilligan, PhD, Chief Executive Officer of Tryp Therapeutics, said, “We are excited to announce completion of Fluence’s training of psychotherapists for our Phase 2a clinical trial in IBS-related pain. Completion of this training marks a significant step forward in the development of our potentially groundbreaking treatment for patients suffering from this debilitating condition. Collaborating with partners like Harvard/MGH and Fluence, a leader in providing psychotherapeutic training for health professionals administering psychedelic compounds to patients,
represents an extraordinary opportunity to advance the field of psychedelic medicine and improve the lives of countless patients.”
About Tryp Therapeutics
Tryp Therapeutics is a clinical-stage biotechnology company focused on developing proprietary, novel formulations for the administration of psilocin in combination with psychotherapy to treat diseases with unmet medical needs. Tryp’s lead program, TRP-8803, is a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe. The Company has an ongoing Phase 2a clinical trial for the treatment of Binge Eating Disorder at the University of Florida, an upcoming Phase 2a clinical trial with the University of Michigan for the treatment of fibromyalgia and a planned Phase 2a trial for the treatment of irritable bowel syndrome at Mass General Hospital, all of which are utilizing TRP-8802 (synthetic, oral psilocybin) to demonstrate efficacy in these indications. Where a preliminary clinical benefit has been demonstrated, subsequent studies are expected to utilize TRP-8803 (IV-infused psilocin) which has the potential to further improve efficacy, safety and patient experience. For more information, please visit www.tryptherapeutics.com.
Investor & Media Contact
Peter Molloy
Chief Business Officer
Tryp Therapeutics
pmolloy@tryptherapeutics.com
Forward-Looking Information
Certain information in this news release constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans,” “targets,” “expects” or “does not expect,” “is expected,” “an opportunity exists,” “is positioned,” “estimates,” “intends,” “assumes,” “anticipates” or “does not anticipate” or “believes,” or variations of such words and phrases or state that certain actions, events or results “may,” “could,” “would,” “might,” “will” or “will be taken,” “occur” or “be achieved.” In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.
Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of Tryp’s final prospectus available at www.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.
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