Cybin Inc. has partnered with Thermo Fisher Scientific to support the clinical development and potential commercialization of CYB003, a proprietary deuterated psilocin treatment targeting major depressive disorder (MDD). The strategic collaboration will expand Cybin's manufacturing capabilities across two U.S. facilities, with Thermo Fisher handling drug substance production in South Carolina and capsule manufacturing in Ohio.
The partnership comes on the heels of CYB003 receiving FDA Breakthrough Therapy Designation in March 2024, signaling the potential significance of this novel mental health treatment. Previous Phase 2 clinical trials demonstrated exceptional outcomes, including a 100% response rate and 71% remission with two 16 mg doses, highlighting the treatment's promising therapeutic potential.
This collaboration represents a critical milestone in psychedelic-based mental health therapeutics. By leveraging Thermo Fisher's extensive manufacturing expertise, Cybin is positioning itself to potentially deliver an innovative treatment option for individuals struggling with major depressive disorder, a condition that affects millions globally.
The ongoing Phase 3 PARADIGM trial will be crucial in determining CYB003's efficacy and safety profile. If successful, the treatment could offer a groundbreaking alternative for patients who have not responded to traditional antidepressant therapies.
