Tryp Therapeutics (CSE:TRYP) (OTCQB:TRYPF), a clinical-stage biotech company, said Wednesday that it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for a Phase 2a clinical trial targeting irritable bowel syndrome treatment.
The trial will focus on patients 21 and older who suffer from treatment-resistant IBS, a condition characterized by chronic abdominal pain and other debilitating gastrointestinal symptoms. Collaborating with Harvard Medical School and Massachusetts General Hospital, Tryp seeks to explore the potential benefits of psilocybin-assisted psychotherapy for this patient group.
Central to the therapeutic approach is Tryp’s proprietary intravenous formulation of psilocin, known as TRP-8803. The method aims to address several challenges associated with oral psilocybin, with quicker onset of the psychedelic state, better control over the depth and duration of the psychedelic experience, and a shorter overall duration of the intervention.
Jim Gilligan, PhD, Tryp’s CEO, noted that the study will explore how psilocybin-assisted psychotherapy might change brain networks related to chronic abdominal pain and gastrointestinal-specific anxiety in IBS patients, thereby improving their symptoms.
Underscoring the significance of the IND submission, Gilligan called the move “an important step in advancing our program.”
In an interview with Green Market Report, Gilligan likened the planned administration of psilocin to the work of anesthesiologists. Using an IV to induce and subsequently awaken the patient from the psychedelic state, the approach might also allow for the use of serotonin antagonists to terminate the psychedelic experience, if necessary.
“We’re looking at things a little bit differently than the big guys, looking at unique areas where we can have first-mover advantage. But we’re judicious in selecting areas where we really think that we’ll have a positive outcome,” he said.
“The most important thing is a clinical data – to be able to not just assume or hypothesize that we’re going to have a benefit, but to actually demonstrate that we can do something positive for patients”
The company’s chief business officer, Peter Molloy, said that the FDA had advised the company to initially conduct studies using oral psilocybin before transitioning to the use of the IV formulation.
“That’s a strategy that reduces the cost, reduces the risk. And that creates a much more advantageous commercial pathway forward,” he said.
Wednesday’s announcement follows January news of Tryp’s promising initial results from a Phase 2a oral psilocybin-assisted therapy trial. The trial recorded significant reductions in patients’ binge-eating episodes, setting a stage for further development and trial testing of IV-channeled psilocin, psilocybin’s active metabolite.
The company is currently conducting a Phase 2a clinical trial at the University of Florida.
Tryp’s progress and strategic partnerships have recently attracted financial backing, too. Last month, the company secured $2.4 million in private placement funding, which will support its research and development programs as well as for general working capital.