Cybin Inc. Begins Phase 3 Trials, Betting Big On CYB003 To Treat Depression
Cybin Inc. (AMEX:CYBN) has launched its Phase 3 pivotal program called PARADIGM, which is aimed at testing the efficacy of its lead candidate, CYB003, for treating Major Depressive Disorder (MDD) in a move that comes after three years of development.
“Just three years after filing an Investigational New Drug application for CYB003, the initiation of our Phase 3 program is a truly significant and gratifying milestone,” said Doug Drysdale, CEO of Cybin.
The design of the PARADIGM program, according to Drysdale, has been shaped by a collaborative process with the Food and Drug Administration (FDA), taking into account the challenges faced by other companies in this space. He said the trials are recruiting from a broader MDD population, allowing patients to stay on their existing antidepressant regimen while testing CYB003 as an additional treatment.
“The program name, PARADIGM, represents our belief that CYB003 could have the potential for a paradigm shift in the treatment of depression,” the company shared in a press release.
Breaking Down The Phase 3 Program
The PARADIGM program consists of three key studies:
- APPROACH will enroll 220 participants across 36 sites in the U.S. and Europe. The study compares a 16 mg …