Thermo Fisher Scientific Inc. has been engaged by Cybin Inc. to provide U.S.-based manufacturing support for its CYB003 program, a proprietary deuterated psilocin program in Phase 3 development for the adjunctive treatment of Major Depressive Disorder (MDD). This partnership covers both Phase 3 clinical supply and potential commercial manufacturing.
Thermo Fisher’s pharma services sites in Florence, South Carolina, will handle Phase 3 clinical supply and future commercialization, while the Cincinnati, Ohio, facility will be responsible for Phase 3 capsule production and commercialization. This collaboration is crucial for advancing CYB003, which received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation in March 2024.
The FDA Breakthrough Therapy Designation provides an expedited review pathway and the potential to accelerate drug development timelines, acknowledging the significant unmet medical need for more effective MDD treatments. This partnership highlights Thermo Fisher's role in supporting innovative therapies and expanding its contract development and manufacturing capabilities in high-growth areas.
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