Cybin Partners with Thermo Fisher for U.S. Manufacturing

LOS ANGELES- Cybin Inc. a neuropsychiatry company, has announced a collaboration with Thermo Fisher Scientific to support the Phase 3 clinical supply and potential commercial manufacturing of CYB003, its proprietary deuterated psilocin analog, for the adjunctive treatment of Major Depressive Disorder (MDD).

Manufacturing Agreement Details

Under the agreement, Thermo Fisher will provide both the drug substance and capsule drug product for CYB003. Manufacturing activities will be conducted at Thermo Fisher’s pharmaceutical services sites in Florence, South Carolina, and Cincinnati, Ohio. This partnership expands upon the existing relationship between the two companies and aligns with Cybin’s strategy to establish domestic manufacturing infrastructure as it advances toward commercialization.

CYB003 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) in March 2024, a designation that offers benefits such as expedited development and review. This decision was based on Phase 2 results showing a 100% response rate and 71% remission rate at 12 months among patients who received two 16 mg doses. In November 2024, Cybin initiated the PARADIGM™ program, a multinational Phase 3 study aimed at further evaluating the efficacy and safety of CYB003 in a broader MDD patient population.

Statements from Company Executives

Doug Drysdale, CEO of Cybin, stated, “Thermo Fisher, which offers leading Contract Development and Manufacturing Organization (CDMO) services, has a successful track record across the manufacturing spectrum, and their expertise will help to accelerate our drug development trajectory.” Aaron Bartlone, Chief Operating Officer of Cybin, added, “Affiliating with a world-class manufacturing partner is critical for us as we advance this important program and address a significant unmet medical need in the treatment of mental health disorders.”

Founded in 2019, Cybin is a late-stage neuropsychiatry company focused on developing innovative treatment options for mental health conditions. In addition to CYB003, the company is developing CYB004, a proprietary deuterated N,N-dimethyltryptamine molecule currently in Phase 2 studies for generalized anxiety disorder. Cybin operates in multiple countries, including Canada, the United States, the United Kingdom, the Netherlands, and Ireland.