Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF), a pharmaceutical company focused on developing psilocybin-based compounds for diseases with unmet medical needs, reported that the U.S. Food and Drug Administration (“FDA”) has placed a clinical hold on its upcoming Phase 2a study for eating disorders. According to the announcement, the FDA did not cite a reason for the hold but would provide additional information regarding the hold in the next month. Although the study is now on hold, the company noted that it still expects to move forward with plans to file an IND for its Phase 2a study in fibromyalgia; that study is being conducted with the University of Michigan. Tryp will also continue to focus on two academic collaborations for Phase 2a clinical trials; one will focus on phantom limb pain and one will focus on complex regional pain syndrome. “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 Tryp Therapeutics CEO and chair Greg McKee in the press release. “We cannot comment on the deficiencies that led to the FDA’s decision to place our upcoming Phase 2a 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.”
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About Tryp Therapeutics Inc.
Tryp Therapeutics is a pharmaceutical company focused on developing psilocybin-based compounds for the treatment of diseases with unmet medical needs through accelerated regulatory pathways. Tryp’s psilocybin-for-neuropsychiatric disorders, or PFN(TM) (“PFN”), program is focused on the development of synthetic psilocybin as a new class of drug for the treatment of chronic pain and eating disorder indications. The company has announced upcoming Phase 2a clinical trials with the University of Michigan and the University of Florida to evaluate its drug products for fibromyalgia and eating disorders, respectively. Tryp is also developing a proprietary psilocybin-based product, TRP-8803, that uses a novel formulation and method of delivery to improve the patient experience. For more information about the company, please visit www.TrypTherapeutics.com.
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