There’s a Phase III clinical trial getting started that is aiming to validate a synthetic form of psilocybin as a therapeutic. Could it become the first psychedelic drug to get regulatory approval in the United States?
What’s happening:
- Cybin (NYSE: CYBN) is launching their Phase III clinical trial for their novel psychedelic therapeutic CYB003 for the treatment of major depressive disorder
Why it matters:
- Cybin is one of the most advanced publicly listed psychedelic drug developers and previously was awarded a Breakthrough Therapy designation from the United States Food and Drug Administration for CYB003
By the numbers:
- The first study included in the Phase III trial which Cybin has already launched will enroll 220 patients across 36 different clinical sites in both the United States and Europe
- Currently, Cybin has $154M CAD in total cash to fund clinical trials and further drug development
Going deeper:
- Cybin previously saw enormously encouraging patient outcomes from their Phase II clinical trial for CYB003, which validated that patients with major depressive disorder saw a meaningful reduction in symptoms after just one single dose of CYB003
- The United States Food and Drug Administration is still yet to officially approve any new psychedelic compounds to be legally prescribed to patients, but with more and more late stage clinical trials for psychedelic medicines being advanced that could likely be on the verge of finally changing
The intrigue:
- Psychedelic medicine companies have continued to garner significant excitement from investors, with ibogaine drug development startup Soneira recently landing Google (NASDAQ: GOOG) co-founder Sergey Brin as a backer
