Cybin, a neuropsychiatry company, recently held a successful meeting with the FDA regarding its Type B Breakthrough Therapy for their drug CYB003. The drug targets the treatment of Major Depressive Disorder (MDD).
Cybin’s Phase 3 pivotal trial will commence in late summer 2024. The study will involve 30 clinical sites throughout the United States and Europe with expertise in depression research.
In Phase 2 trials, CYB003 demonstrated promising efficacy, with 75% of patients achieving remission from depression four months after receiving two 16mg doses. Cybin anticipates releasing 12-month efficacy data from the Phase 2 study later this year.
To mitigate the risk of functional unblinding, the Phase 3 trial will incorporate measures such as adaptive masking, participant blinding, and manual and AI monitoring.
In addition to the trial updates, Cybin has realigned the composition of its Governance and Nominating Committee and Compensation Committee, which will now consist solely of independent directors.
Cybin’s mission remains to develop innovative and effective treatments for mental health conditions. They aim to revolutionize mental healthcare through collaborations with world-class partners and scientific experts. Cybin’s research pipeline includes CYB003 for MDD, CYB004 for generalized anxiety disorder, and other psychedelic-based compounds.
With its ongoing FDA collaboration and advancements in clinical development, Cybin is poised to bring new hope to individuals suffering from depression and other mental health concerns.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
