The company previously announced on October 20, 2021 a clinical hold placed on the study by the FDA. The Company provided an update on the matter on November 18, 2021 and submitted an amendment to the FDA for the Investigational New Drug (IND) application on December 9, 2021. Through the notice received this week, the FDA removed the clinical hold and advised Tryp that it can continue with the study.
Commenting on the development, Chairman and CEO Greg McKee said, “We are excited to move forward with our Phase 2a clinical trial in binge eating disorder through our partnership with the University of Florida. Our dialogue with the FDA has been productive and has meaningfully improved the design of this study. This represents the second clinical study in 2021 that we have received authorization from the FDA to initiate.”