Biotech Company Seeks FDA Approval for Psilocybin IBS Treatment

Tryp Therapeutics announced Wednesday that it has “submitted an Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA) for its planned Phase 2a clinical trial evaluating the effects of psilocybin-assisted psychotherapy treating patients as young as 21 years of age.” + Have Irritable Bowel Syndrome (IBS) at Massachusetts General Hospital (MGH).”

The Canadian company said in the announcement that 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 irritable bowel syndrome who are suffering from chronic abdominal pain and other debilitating gastrointestinal disorders -Symptoms suffer.” .”

“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 examine changes in brain connectivity and responses to pain at baseline, four weeks, six months and 12 months after the psychedelic drug sessions, as well as numerous other secondary endpoints,” the announcement said.

“Tryp and our collaborators at Harvard/MGH believe there is tremendous potential for treating debilitating IBS symptoms through the combined administration of psilocybin and psychotherapy. The clinical study examines how psilocybin-assisted psychotherapy can alter the brain networks involved in chronic abdominal pain and gastrointestinal anxiety in patients with irritable bowel syndrome to improve their symptoms. The filing of IND 163994 is an important step in advancing our program,” said Jim Gilligan, CEO of Tryp Therapeutics.

Gilligan told Green Market Report that “what’s important is clinical data — not just to be able to assume or hypothesize that we’re going to have a benefit, but to actually show that we can do something positive for patients.”

“We look at things a little differently than the big guys and look at unique areas where we can have a first-mover advantage. But we are careful in selecting the areas where we genuinely believe we will have a positive result,” Gilligan said.

According to the Green Market Report, Gilligan “likened the planned administration of psilocin to the work of anesthesiologists.”

“By using an IV to induce and subsequently wake the patient from the psychedelic state, the approach could also allow for the use of serotonin antagonists, if needed, to end the psychedelic experience,” said the outlet, which noted that TRP -8803 “of central importance” to the company’s therapeutic approach.

TRP-8803 is “Tryp’s lead program,” the company says, describing it as “a proprietary formulation of intravenously infused psilocin (the active metabolite of psilocybin) that alleviates numerous deficiencies of oral psilocybin, including: time to disease onset significantly shortened.” to improve the psychedelic state, control the depth and duration of the psychedelic experience, and reduce the overall duration of the intervention to a commercially feasible time frame.

“The Company is conducting an ongoing Phase 2a clinical trial in the treatment of binge eating disorder at the University of Florida, an upcoming Phase 2a clinical trial in the treatment of fibromyalgia with the University of Michigan, and a planned Phase 2a Study to treat irritability from bowel syndrome at Mass General Hospital, all using TRP-8802 (synthetic, oral psilocybin) to demonstrate efficacy in these indications. Once preliminary clinical benefit has been demonstrated, subsequent studies are expected to utilize TRP-8803 (IV-infused psilocin), which has the potential to further improve efficacy, safety and patient experience,” Tryp said in the announcement dated Wednesday.