Neuropsychiatry company Cybin has inked a manufacturing agreement with Thermo Fisher Scientific to support the late-stage development of CYB003, a deuterated psilocin analog currently in Phase 3 trials as an adjunctive treatment for major depressive disorder (MDD).
Under the agreement, Thermo Fisher will provide capsule supply for Phase 3 trials and support future commercial production. Manufacturing will include both drug substance and drug product.
Manufacturing activities will be carried out at Thermo Fisher’s U.S.-based pharmaceutical services sites in Florence, South Carolina, and Cincinnati, Ohio. The partnership expands on an existing relationship between the 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 in March 2024, a designation that offers benefits such as expedited development and review. The decision was based on Phase 2 results showing a 100% response rate and 71% remission rate at 12 weeks among patients who received two 16-mg doses.
“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,” Cybin CEO Doug Drysdale said in a statement.
Cybin launched its multinational Phase 3 program, called PARADIGM, in late 2024 to evaluate the treatment across a broader patient population. The company is also developing CYB004, a deuterated N, N-dimethyltryptamine molecule in Phase 2 trials for generalized anxiety disorder, and has a research pipeline focused on serotonin receptor-targeting compounds.