FDA Grants Cybin Breakthrough Therapy Status For Major Depression Psilocybin Therapy, Company Announces Positive Clinical Data & Canadian $150M Private Placement
Clinical-stage psychedelics biopharma company Cybin Inc. (NYSE:CYBN) announced that the Food and Drug Administration has granted Breakthrough Therapy designation to CYB003, its proprietary deuterated psilocybin analog targeting the adjunctive treatment of Major Depressive Disorder (MDD.)
The news follows the same granted designation to MindMed’s (NASDAQ:MNMD) LSD-derived treatment for Generalized Anxiety Disorder (GAD.)
Further, it makes the group of psychedelic-based treatments for mental health conditions that have in recent years received such status granted by the U.S. federal agency five therapies total: the mentioned two, plus MAPS’ MDMA-assisted therapy for PTSD treatment and Compass Pathways’ (NASDAQ:CMPS) psilocybin therapy targeting Treatment-Resistant Depression (TRD.)
Designation’s Enabling Features
Breakthrough Therapy designation provides an expedited review pathway, with fast-track program features as well as increased access to FDA guidance and discussion on the therapy’s development program including trial design and expedited manufacturing development strategy, with the potential to significantly reduce drug development timelines.
It is granted to drug candidates that target serious conditions and demonstrate substantial improvement on a clinically significant endpoint as compared to available therapies.
Supported by the positive topline results from Cybin’s Phase 2 study of CYB003 in MDD, the company says the designation acknowledges the significant unmet medical need for more effective treatments of MDD and supports CYB003’s potential for significant improvements over existing therapies. If approved by the FDA, it would be the first known adjunctive psychedelic-based therapeutic for the treatment of MDD.
CEO Doug Drysdale stated that the designation underscores CYB003’s potential “to fill a gap in the treatment landscape for MDD” and also “serves to expedite and de-risk” the company’s drug development program going forward.
“This designation provides for a streamlined review process and enhanced engagement with the FDA. With the robust durability data from our Phase 2 …