Tryp Therapeutics Receives Confirmation From FDA To Proceed With Phase 2A Clinical Trial in Patients With IBS at Massachusetts General Hospital

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 it has received confirmation from the U.S. Food and Drug Administration (“FDA”) that its review of Tryp’s Investigational New Drug (“IND”) #163,994 is complete and that the Company may proceed with its Phase 2a clinical trial at Massachusetts General Hospital (MGH) investigating the effects of psilocybin-assisted psychotherapy in the treatment of patients aged 21+ suffering from Irritable Bowel Syndrome (IBS).

The planned study in collaboration with Massachusetts General Hospital 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 which will be measured at four weeks post the final therapist-monitored psychedelic drug session, along with numerous other secondary endpoints including changes in brain connectivity.

“The upcoming Phase 2a study with Harvard Medical School/Massachusetts General Hospital for IBS represents a significant milestone for Tryp’s clinical programs,” added Jim Gilligan, PhD, Chief Executive Officer of Tryp Therapeutics. “We are eager for our collaborators at MGH to complete the work necessary to initiate enrolling patients in the study in the coming months. This novel approach holds great promise for this indication especially considering the limited existing options for these IBS patients.”

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 initiated a Phase 2a clinical trial for the treatment of Binge Eating Disorder at the University of Florida, where an interim analysis showed an average reduction in binge eating episodes of greater than 80%. The Company is also planning for Phase 2a clinical trials with the University of Michigan for the treatment of fibromyalgia and with Mass General Hospital for the treatment of abdominal pain related to irritable bowel syndrome. Each of the studies are utilizing TRP-8802 (synthetic, oral psilocybin) to demonstrate efficacy in these indications. Where a preliminary clinical benefit is demonstrated, subsequent studies are expected to utilize TRP-8803 (IV-infused psilocin), which has the potential to further improve efficacy, safety and patient experience