Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF), a pharmaceutical company focused on developing psilocybin-based compounds for diseases with unmet medical needs, today announced that it has submitted an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) to evaluate its clinical candidate, TRP-8802, in a phase 2a clinical trial. Conducted with Kevin Boehnke, Ph.D. from the University of Michigan, the trial seeks to investigate safety and preliminary effectiveness of psilocybin-assisted therapy among patients with fibromyalgia in collaboration with the University of Michigan and will evaluate the company’s oral formulation of synthetic psilocybin, TRP-8802, in combination with psychotherapy. The application includes the trial protocol and safety information details, and Tryp expects to initiate the phase 2a study in 2022 subject to a favorable review of the IND by the FDA. “Many fibromyalgia patients find insufficient relief from the currently available, FDA-approved treatments for the disease due to their limited efficacy and significant side effects,” said Dr. Boehnke. “We have an opportunity with Tryp to conduct a phase 2a study that evaluates the safety and clinical utility of psilocybin for fibromyalgia as we target the origins of the disease rather than simply treating patient symptoms.”
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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 PFN(TM) (“PFN”) program is focused on the development of synthetic psilocybin as a new class of drug for the treatment chronic pain and other 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 route of administration to improve the patient experience. For more information about the company, visit www.TrypTherapeutics.com.
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