pharmaphorum March 14, 2024
It has been a busy week for psychedelic medicines developer Cybin, marked by a breakthrough designation (BTD) from the FDA for its depression therapy, new clinical data, and a new $150 million private placement.
The Toronto, Canada company says that the BTD is the first to be awarded for an adjunctive psychedelic-based therapy for the treatment of major depressive disorder (MDD), and comes as its CYB003 showed durable antidepressant effects over four months in a phase 2 trial.
The new data showed that 75% of patients who had received two 16 mg doses of deuterated psilocybin analogue CYB003 – given three weeks apart and on top of current antidepressant drugs – were in remission at that time point, as measured...