- Cybin has partnered with Thermo Fisher Scientific to support Phase 3 clinical supply and potential commercial manufacturing of CYB003 for Major Depressive Disorder.
- The collaboration involves Thermo Fisher’s CDMO services at its South Carolina and Ohio sites.
Cybin Inc., a clinical-stage neuropsychiatry company, has announced a manufacturing partnership with Thermo Fisher Scientific to support the advancement of CYB003, its proprietary deuterated psilocin therapy for Major Depressive Disorder (MDD). The agreement covers Phase 3 clinical supply and potential commercial production.
CYB003, which received FDA Breakthrough Therapy Designation in March 2024, is currently in Phase 3 development under the PARADIGM™ multinational program. The Phase 2 study of CYB003 demonstrated a 100% response rate and 71% remission rate at 12 months following two 16 mg doses.
Under the partnership, Thermo Fisher will supply both drug substance and capsule drug product. Manufacturing will take place at Thermo Fisher’s pharma services sites in Florence, South Carolina, and Cincinnati, Ohio. The collaboration builds on an existing relationship between the two companies.
Doug Drysdale, CEO of Cybin, said: “Thermo Fisher… has a successful track record across the manufacturing spectrum, and their expertise will help to accelerate our drug development trajectory.”
Thermo Fisher joins Cybin in supporting a therapy aimed at addressing the unmet medical needs in mental health treatment. The partnership reflects Cybin’s efforts to secure scalable CDMO support as it moves toward potential commercialisation of CYB003.
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