TRYP THERAPEUTICS SUBMITS INVESTIGATIONAL NEW DRUG (IND) APPLICATION TO US FDA FOR PLANNED PHASE 2a CLINICAL TRIAL IN PATIENTS WITH IBS AT MASSACHUSETTS GENERAL HOSPITAL
KELOWNA, BC / ACCESSWIRE / May 24, 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 submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) 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 planned open label study in collaboration with Harvard Medical School/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. The proposed study will also explore changes in brain connectivity and responses to pain at baseline and at four weeks, six months and twelve months post the psychedelic drug sessions, along with numerous other secondary endpoints.
In recognition of this important development, Jim Gilligan, PhD, Chief Executive Officer of Tryp Therapeutics, said, "Tryp and our collaborators at Harvard/MGH believe there is tremendous potential for the treatment of debilitating IBS symptoms by utilizing the combined administration of psilocybin and psychotherapy. The clinical study will examine how psilocybin-assisted psychotherapy may alter brain networks involved in chronic abdominal pain and gastrointestinal-specific anxiety in patients with IBS to improve their symptoms. Submission of IND 163994 is an important step in advancing our program."
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SOURCE: Tryp Therapeutics
05/24/2023 EQS Newswire / EQS Group AG