Tryp Therapeutics announced plans to launch a Phase 2a clinical trial evaluating the potential of its investigational oral candidate TRP-8802 (synthetic psilocybin) at reducing excessive appetite in people with Prader-Willi syndrome (PWS) and other rare disorders characterized by overeating and with high unmet therapeutic needs.
The upcoming trial is being designed in collaboration with Jennifer Miller, MD, a pediatric endocrinologist specialized in PWS and other genetic causes of early-onset excessive weight gain. Miller will be the trial’s principal investigator.
“We are pleased to announce the involvement of Dr. Miller, a leading expert in treating patients with rare eating disorders, in the planning for a clinical trial evaluating the safety, pharmacokinetics and efficacy of TRP-8802,” Jim Kuo, Tryp’s CEO, said in a press release.
Pharmacokinetics refers to a therapy’s movement into, through, and out of the body.
“Our team is excited about the opportunity to advance our PFN [psilocybin for neuropsychiatry disorders] program in a new indication that represents an important advancement in patient care and a significant commercial opportunity for Tryp in rare eating disorders,” Kuo said.
Miller, who also is a professor at the University of Florida and the director of its PWS program, said “there are currently no approved drugs and only limited options to treat patients with rare over-eating disorders.”
“I’m excited to work with the Tryp team to explore the use of psilocybin as a new paradigm to treat symptoms associated with this devastating medical disease,” she added.
Psilocybin, the psychoactive compound in “magic” mushrooms, is a well-known psychedelic with restricted use in North America and several other countries due to its potential for abuse.
Still, over the last decade it has gained increased interest as a potential treatment for depression — with promising results in a Phase 2 clinical trial — and addiction, with clinical studies ongoing to assess the potential of psychedelics in post-traumatic stress disorder and anorexia nervosa.
In addition, a review study of animal and human data showed that in a medical context, psilocybin does not have a high abuse potential and that there is no clear evidence of a physical dependence potential.
Tryp’s PFN clinical program will evaluate the potential benefits of TRP-8802 — an oral, man-made formulation of psilocybin — in chronic pain conditions, such as fibromyalgia, and eating disorders, such as PWS.
Given that psilocybin has already shown positive effects and is currently being evaluated in conditions characterized by intrusive thoughts, such as those seen in PWS regarding food, the company believes that TRP-8802 may help reduce or eliminate excessive appetite (hyperphagia) in certain PWS patients.
Notably, intrusive thoughts are unwanted thoughts, impulses, or mental images that become stuck in one’s mind, causing anxiety and distress.
Based on data from several previous clinical trials showing that psilocybin is generally well-tolerated, with low toxicity, and no reports of serious adverse side effects in other indications, Tryp believes it can proceed directly into a Phase 2 clinical trial pending clearance from the U.S. Food and Drug Administration.
While the details of the exploratory trial are still being determined, the company expects that all participants will receive the experimental therapy, likely in combination with cognitive behavior therapy.
Cognitive behavioral therapy focuses on teaching people how to identify and change negative patterns of thought.
The main or secondary goal of the trial, which is expected to take place in the U.S., likely will assess changes in hyperphagia, through a validated caregiver-filled questionnaire. But the company also is exploring other possible objective main goals.
Tryp expects to launch two more Phase 2 trials: one to test TRP-8802 in people with fibromyalgia; and the other to evaluate its second therapeutic candidate, TRP-1001, for the treatment of soft tissue sarcomas (a rare type of cancer that affects the tissues that connect, support, and surround other body structures).
The company continues to evaluate additional indications for its existing programs, as well as other therapy candidates with well-characterized safety and/or activity profiles and potential for treating orphan diseases and other conditions with high unmet medical needs.
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