Tryp Therapeutics Receives Confirmation from FDA to Proceed with Phase 2a Study in Fibromyalgia

Tryp Therapeutics (CSE: TRYP), a pharmaceutical company focused on developing psilocybin-based compounds for diseases with unmet medical needs, announced today that it has received confirmation from the U.S. Food and Drug Administration that its review of Tryp’s Investigational New Drug application is complete and that the Company may proceed with its clinical study in fibromyalgia.

The trial is being conducted with Kevin Boehnke, Ph.D. from the University of Michigan and will evaluate the Company’s oral formulation of synthetic psilocybin, TRP-8802, in combination with psychotherapy.  Tryp expects to initiate the Phase 2a study in 2022.

The Phase 2a open label clinical trial will enroll 20 fibromyalgia patients and includes a variety of secondary and exploratory endpoints given the high prevalence of co-morbidities such as poor sleep quality, depression, anxiety, and other conditions in patients suffering from fibromyalgia.  The administration of psilocybin is expected to increase neuroplasticity and to address disrupted neural connections that have been reported for nociplastic pain indications.  The clinical trial will be one of the first evaluations of synthetic psilocybin for fibromyalgia in a Phase 2 study.

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™) program is focused on the development of synthetic psilocybin as a new class of drug for the treatment of 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 overeating 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, please visit www.tryptherapeutics.com.