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Biotech is seeking FDA approval for a Psilocybin-IBS treatment

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Tryp Remedies announce On Wednesday it “submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for a planned Phase 2a clinical trial to investigate the effects of psilocybin-assisted psychotherapy in the treatment of patients over 21 years of age with IBS. Neuropathy (IBS) at Massachusetts General Hospital (MGH).

“An open-label study planned in collaboration with Harvard Medical School/Massachusetts General Hospital will evaluate the effect of psilocybin-assisted psychotherapy in patients with treatment-resistant IBS who present with chronic abdominal pain and other gastrointestinal symptoms,” the Canadian company said in its announcement. .”

Many of these patients also experience fibromyalgia, anxiety, and fatigue. The primary 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 after narcotic drug sessions, along with several other secondary endpoints.

Tryp and our collaborators at Harvard/MGH believe there is huge potential for treating debilitating IBS symptoms through the benefit of co-administration of psilocybin and psychotherapy. The clinical study will examine how psilocybin-assisted psychotherapy can alter brain networks implicated in chronic abdominal pain and gastrointestinal anxiety in IBS patients to improve their symptoms. “The submission of IND 163994 is an important step in the development of our program,” said Jim Gilligan, CEO of Tryp Therapeutics.

Gilligan said Green market report That “the most important thing is the clinical data — to be able to not only hypothesize or hypothesize that we will get a benefit, but to prove that we can do something positive for patients.

“We look at things a little differently than the big players, looking at unique areas where we can have a first-mover advantage. But we’re wise to pick areas where we really think we’re going to get a positive outcome,” Gilligan said.

According to the Green Market Report, Gilligan likened the planned administration of Psilocin to the work of anesthesiologists.

“Using an IV to coax and awaken a patient from a hallucinatory state, the approach may also allow the use of serotonin antagonists to end an anesthetic experience, if needed,” He saidwhich indicated that TRP-8803 would be “central” to the company’s approach to treatment.

TRP-8803 is “Tryp Master Program,” the company says, describing it as “a proprietary formulation of psilocin (the active metabolite of psilocybin) that alleviates many of the shortcomings of oral psilocybin including: Significantly reducing the time to onset of a narcotic state , controlling the depth and duration of the anesthetic experience, and reducing the overall duration of the intervention to a commercially viable time frame.

The Company has an ongoing Phase 2A clinical trial for binge eating disorder at the University of Florida, an upcoming Phase 2A clinical trial with the University of Michigan for fibromyalgia and a planned Phase 2A trial for irritable bowel syndrome at Mass General Hospital, all using TRP. -8802 (oral synthetic psilocybin) to demonstrate efficacy in these indications. Where initial clinical benefit has been demonstrated, subsequent studies are expected to use TRP-8803 (intravenous injected psilocin) which has the potential to further improve efficacy, safety and patient experience,” he said. Tripp in the announcement on Wednesday.

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