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)

Tryp Therapeutics, Inc. (CSE:TRYP | OTCQB:TRYPF), 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.

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.”

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

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.