Tryp Therapeutics and Massachusetts General Hospital Sign Letter of Intent for Clinical Study Investigating the Use of Psilocybin-Assisted Psychotherapy for the Treatment of Patients Suffering From Irritable Bowel Syndrome (IBS)

Rhea-AI Summary

Tryp Therapeutics has signed a letter of intent with Massachusetts General Hospital to conduct a Phase 2a clinical trial assessing psilocybin-assisted psychotherapy for treating Irritable Bowel Syndrome (IBS). IBS affects 4-5% of the population, and current treatments have low satisfaction rates. The trial aims to improve abdominal pain in treatment-resistant patients. Tryp's IV-infused psilocin formulation, TRP-8803, promises advantages over oral psilocybin. The IBS treatment market is projected to reach $4.7 billion by 2030.

Positive

• Partnership with Massachusetts General Hospital for a Phase 2a clinical trial.
• Focus on treatment-resistant IBS patients, addressing a significant unmet medical need.
• Potential for TRP-8803 to enhance treatment efficacy and patient experience.

Negative

• Current dissatisfaction with existing IBS treatments may affect trial enrollment.
• Uncertainty in trial outcomes could impact future developments and investor confidence.

KELOWNA, BC / ACCESSWIRE / January 3, 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 the signing of a letter of intent with Massachusetts General Hospital (MGH), the largest teaching hospital of Harvard Medical School, to fund and conduct a Phase 2a clinical trial investigating the effects of psilocybin-assisted psychotherapy in the treatment of patients aged 21+ suffering from Irritable Bowel Syndrome (IBS). IBS is a common, chronic, and often debilitating condition with an estimated prevalence in the general population ranging from 4-5%. Industry research has demonstrated that a large percentage of IBS patients and gastroenterologists are dissatisfied by current treatments. The market for IBS treatments is estimated to grow to $4.7 billion by 2030*.

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, at four weeks, six months and twelve months, post-the psychedelic session, along with numerous other secondary endpoints.

Dr. Erin Mauney, the pediatric gastroenterology fellow at Massachusetts General Hospital leading the proposed study, said "We are delighted to be partnering with Tryp Therapeutics, a recognized leader in the development of psilocybin-assisted therapies. There is tremendous potential for the treatment of debilitating IBS and other disorders of gut-brain interaction by utilizing the combined administration of psilocybin and psychotherapy. Our clinical study will examine how psilocybin-assisted psychotherapy may alter important brain networks involved in chronic pain and gastrointestinal-specific anxiety in IBS to bolster the neural flexibility in these patients and thereby reduce visceral hypersensitivity."

Jim Gilligan, PhD, Chief Executive Officer of Tryp Therapeutics, commented, "MGH is an ideal partner for Tryp to expand on its strategy of utilizing TRP-8802 (oral psilocybin) to explore the clinical potential of psilocybin-assisted psychotherapy in new indications. With positive results in this study, Tryp would look to continue clinical development in IBS with TRP-8803, our proprietary formulation of IV-infused psilocin, 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. Our ultimate goal is providing even more favorable outcomes and relief to the millions of patients currently suffering from IBS and its associated disorders. With this agreement in place, we will be in a position to submit the relevant IND."

*Asburn & Meera, Nature 2006; Rangan et al, Gastroenterology 2020; Acumen Research and Consulting 2022

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 and an upcoming Phase 2a clinical trial with the University of Michigan for the treatment of fibromyalgia, both 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 which has the potential to further improve efficacy, safety and patient experience. For more information, please visit www.tryptherapeutics.com.

About Massachusetts General Hospital

Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The Mass General Research Institute conducts the largest hospital-based research program in the nation, with annual research operations of more than $1 billion and comprises more than 9,500 researchers working across more than 30 institutes, centers and departments. In July 2022, Mass General was named #8 in the U.S. News & World Report list of "America's Best Hospitals." MGH is a founding member of the Mass General Brigham healthcare system.

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.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

Contact Information

Peter Molloy
Chief Business Officer
pmolloy@tryptherapeutics.com

SOURCE: Tryp Therapeutics

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FAQ

What is Tryp Therapeutics' clinical trial about?

The trial investigates psilocybin-assisted psychotherapy for treating IBS, focusing on chronic abdominal pain.

When is the clinical trial planned to start?

The specific start date has not been disclosed in the press release.

What are the endpoints for the IBS clinical trial?

The primary endpoint is improvement in abdominal pain; secondary endpoints include changes in brain connectivity and pain response.

How does TRP-8803 differ from oral psilocybin?

TRP-8803 is IV-infused, potentially offering quicker onset and better control over the treatment experience.

What is the market potential for IBS treatments?

The IBS treatment market is projected to grow to $4.7 billion by 2030.