Biotech Company Seeks FDA Approval For Psilocybin-IBS Treatment

Trip Therapeutics announced On Wednesday, the company announced that it had submitted an investigational new drug (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 2a clinical trial that will investigate the effects of psilocybin-assisted psychotherapy in treating patients over the age of 21 who suffer from: ) has submitted an application.” Irritable Bowel Syndrome (IBS) at Massachusetts General Hospital (MGH). ”

In a statement, the Canadian company said: “An open-label study, planned in collaboration with Harvard Medical School/Massachusetts General Hospital, will investigate psilocybin in patients with treatment-resistant IBS who experience chronic abdominal pain and other debilitating gastrointestinal symptoms. We plan to evaluate the effects of supportive psychotherapy.” ”

“Many of these patients also suffer from fibromyalgia, anxiety and fatigue. The primary efficacy endpoint of this study is improvement in abdominal pain. We also plan to investigate changes in brain connectivity and pain responses at 4 weeks, 6 months and 12 months after psychedelic drug sessions, as well as a number of other secondary endpoints,” the announcement said. ing.

“Trip and Harvard/MGH collaborators believe that the combined administration of psilocybin and psychotherapy has great potential for the treatment of debilitating IBS symptoms. In this clinical study, psilocybin-based psychotherapy can alter the brain networks involved in chronic abdominal pain and gastrointestinal anxiety in patients with IBS to improve symptoms.The submission of IND 163994 is an important step forward in our program. ” said Jim Gilligan, CEO of Tryp Therapeutics.

Gilligan said. green market report “The most important thing is the clinical data, not just assuming or hypothesizing that it works, but actually demonstrating that it can do something positive for patients.”

“We think a little differently than the big companies and look at unique areas where we can get a first-mover advantage. We choose wisely,” Gilligan said.

According to the Green Market Report, Gilligan “compared the planned administration of thylocine to the work of an anesthesiologist.”

“This approach of using an IV to induce a patient into a psychedelic state and then arousal may also allow the use of serotonin antagonists to end the psychedelic experience if desired,” the report said. agency said. Saidsaid TRP-8803 is “at the center of” the company’s approach to therapy.

TRP-8803 is “Tryp’s lead program,” which the company describes as “a proprietary formulation of intravenously infused psilocycin (the active metabolite of psilocybin) that alleviates many of the drawbacks of oral psilocybin, including: Explaining. It controls the psychedelic state, controls the depth and duration of the psychedelic experience, and shortens the overall duration of the intervention to a commercially viable timeframe.

“We have an ongoing Phase 2a clinical trial for the treatment of bulimia at the University of Florida, an upcoming Phase 2a clinical trial for the treatment of fibromyalgia with the University of Michigan, and an ongoing phase 2a clinical trial for the treatment of hypersensitivity. Phase 2a clinical trials are planned for the purpose of treating bowel syndrome at Massachusetts General Hospital, all of which utilize TRP-8802 (synthetic, oral psilocybin) to demonstrate efficacy in these indications. demonstrating gender. If preliminary clinical efficacy is demonstrated, it is hoped that subsequent studies will utilize TRP-8803 (intravenous thyrosin), which may further improve efficacy, safety and patient experience.” Tryp said in Wednesday’s announcement.