The FDA placed a clinical hold on Tryp Therapeutics’ Phase IIa trial for eating disorders, including binge eating disorder and hypothalamic obesity.
The U.S. Food and Drug Administration (FDA) placed a clinical hold on Tryp Therapeutics’ Phase IIa trial for eating disorders, including binge eating disorder and hypothalamic obesity. No reason was cited for the hold, although Tryp expects additional information within 30 days.
Tryp is developing psilocybin-based drugs. Psilocybin is a naturally occurring psychedelic prodrug generated by more than 200 species of fungi, the so-called “magic mushrooms.” Tryp is developing synthetic psilocybin-based products for a range of diseases, including neuropsychiatric disorders, chronic pain, and eating disorders.
“Our clinical development program is predicated on a positive collaboration with the FDA for the safety and efficacy of our drug products for patients,” said Greg McKee, chairman and chief executive officer of Tryp. “We cannot comment on the deficiencies that led to the FDA’s decision to place our upcoming Phase IIa study on clinical hold at this time. We expect that we will fully resolve any questions from the FDA based on the well-established safety profile of psilocybin across a number of indications and the strength of our clinical trial design. We are confident that we will be able to initiate the clinical trial.”
Tryp plans to file a separate Investigational New Drug (IND) application in the next 10 days for a Phase II trial with the University of Michigan for fibromyalgia. It also has an ongoing academic collaboration for a Phase II trial in phantom limb pain and a Phase IIa trial for complex regional pain syndrome.
The company had submitted the IND for the Phase IIa trial of TRIP-8802 for eating disorders on September 22. The study is to be run with Dr. Jennifer Miller at the University of Florida. TRP-8802 is an oral formulation of synthetic psilocybin and would be evaluated in combination with psychotherapy.
At the time, Miller said, “The submission of this IND represents hundreds of hours of preparation, design, and coordination as we pursue a leading-edge treatment of psilocybin with psychotherapy. I have been thoroughly impressed with the team at Tryp and enjoy our shared commitment to exploring new treatments for our patients who have so few existing therapies available to them.”
The study was planned to enroll 10 patients with a range of overeating disorders, including binge eating, hypothalamic obesity, and Prader-Willi Syndrome. TRP-8802 was expected to increase neuroplasticity and help create healthy neural patterns associated with hunger and eating. The patients would also have sessions with psychotherapists trained by Fluence for two meetings before receiving the drug, which would take place in two drug-dosing sessions. Then additional sessions with the psychotherapists would be conducted afterward.
Two weeks ago, on October 7, Tryp announced a collaboration with Paul Hutson and Christopher Nicholas to support clinical pharmacology studies for its drug, TRP-8803. Hutson and Nicholas are researchers at the University of Wisconsin-Madison. TRP-8803 is a psilocybin-based molecule evaluated for chronic pain indications such as fibromyalgia and phantom limb pain.
Hutson stated, “I am excited to work with Tryp to assess the unique features of their proprietary drug product, TRP-8803. Psilocybin-based treatments have incredible clinical potential. Our collaboration will explore important safety and dosing considerations with the potential to create a best-in-class psychedelic therapy with significant benefits to patients across a wide range of indications.”
