Psilocybin For IBS Gets FDA Nod To Begin Clinical Trials At Mass. General Hospital

Tryp Therapeutics’ TRYPF latest Investigational New Drug (IND) application was approved by the FDA, enabling the company to begin Phase 2a clinical trials at the Massachusetts General Hospital (MGH) on the effects of psilocybin-assisted psychotherapy for adults with Irritable Bowel Syndrome (IBS).

The clinical-stage biotech company is focused on developing novel IV-infused psilocin treatments. Its lead psilocin compound TRP-8803 is currently being assessed in a Phase 2a trial for the treatment of binge eating disorder at the University of Florida where an interim analysis reportedly showed an average reduction of +80% in binge eating episodes. 

Meanwhile, its synthetic oral psilocybin, TRP-8802, is set to be studied in a Phase 2a trial with the University of Michigan for the treatment of fibromyalgia, as well as in the recently-approved Phase 2a study assessing its effects in patients with treatment-resistant IBS experiencing chronic abdominal pain and other gastrointestinal symptoms while also potentially suffering from fibromyalgia, anxiety and fatigue.

The trial’s primary efficacy endpoint is the improvement in abdominal pain, measured at four weeks after the last monitored drug administration. Secondary endpoints include changes in brain connectivity.

"Research indicates a possibility for addressing IBS and other disorders of gut-brain interaction using a combined approach of psilocybin and psychotherapy," said MGH physician and study PI Dr. Erin Mauney, who added that the team is wrapping up preparations to begin patient enrollment.

Tryp’s CEO Dr. Jim Gilligan says the Phase 2a study with Harvard Medical School/MGH for IBS represents a major milestone for the company’s clinical programs and that the novel therapeutic approach holds “great promise” for IBS patients, especially in view of the few existing options.

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Photo: Benzinga edit with photo by Cannabis_Pic and Gorodenkoff and Troyan on Shutterstock.