Cybin Engages Thermo Fisher Scientific to Provide US-Based Manufacturing for its CYB003 Program for the Adjunctive Treatment of Major Depressive Disorder

Cybin Inc. recently announced it has engaged Thermo Fisher Scientific 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).

“This is an exciting time for Cybin as we focus on the execution of our Phase 3 CYB003 pivotal program,” said Doug Drysdale, Chief Executive Officer of Cybin. “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. We are pleased to broaden our existing strong relationship with Thermo Fisher for both the drug substance and drug product capsules for CYB003. 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.”

“Affiliating with a world-class manufacturing partner is critical for us as we advance this important program and address a significant unmet medical need in the treatment of mental health disorders,” said Aaron Bartlone, Chief Operating Officer of Cybin.

Vincent Hingot, President Drug Substance, Pharma Services, at Thermo Fisher, added “We are proud to partner with Cybin on their groundbreaking CYB003 program. Our collaboration underscores our commitment to leveraging our advanced manufacturing capabilities to support innovative treatments that address significant unmet medical needs in mental health.”

In March 2024, CYB003 received US 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.

Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions.

With industry leading proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The company also has a research pipeline of investigational, 5-HT-receptor focused compounds.

Founded in 2019, Cybin is operational in Canada, the US, the UK, the Netherlands, and Ireland. For more information, visit www.cybin.com.