Cybin Receives FDA Clearance for Clinical Trial of Psilocybin Analog to Treat MDD

Cybin, a Toronto-based biopharmaceutical company, announced on Monday that it has received a “may proceed letter” and investigational new drug application clearance from the Food and Drug Administration for a Phase 1/2a clinical trial to evaluate CYB003, its proprietary deuterated psilocybin analog that is being developed as a potential treatment for major depressive disorder (MDD).

With the approvals from the FDA, CYB003 becomes the field’s first novel psilocybin analog to enter clinical development. Cybin said in a news release that it will begin recruiting patients immediately and expects to provide an interim pharmacokinetic and safety data readout in the fourth quarter of 2022.

“We are extremely pleased to advance CYB003 into clinical development so quickly,” Cybin CEO Doug Drysdale said in the release. “Our team has worked diligently to achieve this major regulatory milestone, and we look forward to collaborating with Clinilabs, our drug development partner, to accelerate this program.”

The Phase 1/2a trial is a randomized, double-blind, placebo-controlled study that will evaluate patients with moderate to severe MDD. Participants will receive 2 administrations of either CYB003 or a placebo 3 weeks apart. Response/remission will be assessed after week 3 and week 6 of the trial. Trial participants currently being treated with selective serotonin reuptake inhibitors will be allowed to remain on their antidepressant medication.

Reference

Cybin receives FDA IND clearance for its Phase 1/2a clinical trial evaluating CYB003 for the potential treatment of major depressive disorder. News release. Cybin. June 27, 2022. Accessed June 28, 2022.