The biopharma Cybin Inc. (NYSEAMERICAN:CYBN) has filed a submission of an Investigational New Drug (IND) application with the FDA for its Phase 1/2a first-in-human clinical trial focused on CYB003.
CYB003 is a proprietary psilocybin analog as a proposed treatment of major depressive disorder (MDD) as an adjunct to psychotherapy.
The study would enroll approximately 40 patients, according to a description on ClinicalTrials.gov. The trials would focus on studying the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of CYB003 in patients with MDD.
The proposed study would use the Montgomery-Asberg Depression Rating Scale to gauge improvements in mood and other parameters.
Psilocybin has received a growing amount of interest in recent years. The compound is the focus of more than 50 studies, including Phase 2 studies focused on depressive and post-traumatic stress disorders.
Cybin is also investigating the potential of …