Cybin Inc. Engages Thermo Fisher Scientific to Provide U.S.-Based Manufacturing for Its Cyb003 Program for the Adjunctive Treatment of Major Depressive Disorder

Published: 2025-05-15 07:30:00 ET TMO

Published on 05/15/2025 at 07:30, updated on 05/15/2025 at 08:35

Cybin Inc. announced that it has engaged Thermo Fisher Scientific ("Thermo Fisher"), to support the Phase 3 clinical supply and potential commercial manufacturing of CYB003, the Company's proprietary deuterated psilocin program in Phase 3 development for the adjunctive treatment of Major Depressive Disorder ("MDD"). Cybin has established its manufacturing operations in the United States, including partnering with Thermo Fisher's pharma services sites in Florence, South Carolina, for Phase 3 clinical supply and future commercialization, and Cincinnati, Ohio, for Phase 3 capsule production and commercialization. In March 2024, CYB003 received U.S. Food and Drug Administration ("FDA") Breakthrough Therapy Designation.

Among its many benefits, this designation provides an expedited review pathway and the potential to accelerate drug development timelines. It also includes all "fast track" program features and acknowledges the significant unmet medical need for more effective treatments of MDD. The Company's Phase 2 study results of CYB003 in MDD showed remarkable efficacy at 12 months, including a 100% response rate and a 71% remission rate among participants who received two 16 mg doses.

Based on the strength of the Phase 2 study results, Cybin initiated PARADIGM??, its multinational pivotal Phase 3 program evaluating CYB003 in a broader population of MDD patients, in November 2024.