Pharmaceutical company focused on identifying and developing clinical stage compounds for orphan diseases and unmet medical needs Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) says it has submitted an investigational new drug (IND) application for U.S food and drug administration (FDA) to evaluate its clinical stage candidate TRP-8802 for phase 2a study for treatment of patients with eating disorders.
The study is focused on evaluating the oral formulation of synthetic psilocybin of TRP-8802 in combination with psychotherapy. The IND application entails details concerning the safety drug product, the study method, consent information for patients among other information.
This study will be led by Dr. Jennifer Miller from the University of Florida. The study will seek to commence a phase 2a study subject to a review of the IND by the FDA probably in the fourth quarter of the year.
“The submission of this IND represents hundreds of hours of preparation, design, and coordination as we pursue a leading-edge treatment of psilocybin with psychotherapy. I have been thoroughly impressed with the team at Tryp and enjoy our shared commitment to exploring new treatments for our patients who have so few existing therapies available to them,” said Dr. Miller.