Tryp Therapeutics has received confirmation from the U.S. Food and Drug Administration ("FDA") that its review of Tryp's Investigational New Drug ("IND") 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 upcoming Phase 2a study with the University of Michigan for fibromyalgia represents a significant milestone for Tryp's clinical programs," commented Greg McKee, Chairman and CEO of Tryp Therapeutics. "We are eager to begin enrolling patients in the study next year considering the significant, unmet needs of fibromyalgia patients."

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.