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 correspondence from the U.S. Food and Drug Administration related to the Company’s Investigational New Drug application for a clinical study in overeating disorders.

The FDA has requested certain changes to the protocol of the upcoming study, and Tryp will be modifying the protocol to incorporate all of the FDA’s requests. The primary changes include the following:

  • Focusing enrollment of the initial phase 2a study on patients with binge eating disorder
  • Submitting an IND for a separate phase 2a study to evaluate the use of synthetic psilocybin for patients with hypothalamic obesity

Tryp expects to submit a formal response to the FDA within the next 10 days outlining the modifications to the protocol and informed consent form for the study to comply with the requests. The FDA has indicated that it will then respond to the modifications within 30 days.

Commenting on the development, Greg McKee, Chairman and CEO of Tryp, stated, “We appreciate the feedback from the FDA on our clinical activities for binge eating disorder and hypothalamic obesity patients. We look forward to advancing our synthetic psilocybin programs for the benefit of patients and clinicians alike.”

About Tryp Therapeutics

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