Cybin Partners with Thermo Fisher to Advance CYB003 Manufacturing

News Summary

Cybin Inc. has teamed up with Thermo Fisher Scientific to enhance the manufacturing of CYB003, a novel treatment for Major Depressive Disorder (MDD). This collaboration aims to streamline drug development and improve efficiency as CYB003 progresses through Phase 3 clinical trials. Manufacturing will occur in South Carolina and Ohio, leveraging Thermo Fisher’s expertise. The FDA has granted CYB003 Breakthrough Therapy Designation, emphasizing its potential for addressing unmet needs in MDD treatment. This partnership is crucial in meeting the urgent demand for effective mental health therapies.

Columbia, South Carolina – Cybin Inc. has announced a partnership with Thermo Fisher Scientific aimed at advancing the manufacturing of CYB003, its proprietary deuterated psilocin program, which is currently in Phase 3 clinical development as an adjunctive treatment for Major Depressive Disorder (MDD). This collaboration seeks to enhance drug development efficiency and streamline the manufacturing processes crucial for the upcoming clinical trials and commercialization of CYB003.

The manufacturing of CYB003 will take place at Thermo Fisher’s facilities in Florence, South Carolina, and Cincinnati, Ohio. This strategic partnership is designed to leverage Thermo Fisher’s expertise in high-quality pharmaceutical manufacturing, allowing Cybin to accelerate the production timeline of its innovative treatment.

Cybin’s Chief Executive Officer, Doug Drysdale, emphasized the importance of their relationship with Thermo Fisher in optimizing drug development processes. This partnership comes at a critical juncture, as MDD remains a significant public health concern, with millions of individuals affected by this condition and a growing need for effective treatment options.

Furthermore, Cybin’s Chief Operating Officer, Aaron Bartlone, pointed out the necessity of collaborating with a top-tier manufacturing entity to meet the urgent demands of mental health treatments. The need for effective therapies for MDD is more pressing than ever, and this partnership is positioned to address these challenges head-on.

The FDA granted CYB003 Breakthrough Therapy Designation in March 2024, which allows for an expedited review process intended to accelerate the drug’s development timeline. This designation underscores the potential of CYB003 to address unmet medical needs in treating Major Depressive Disorder.

In previous studies, CYB003 demonstrated promising outcomes, showing a 100% response rate and a 71% remission rate at 12 months among participants who received two doses of 16 mg during Phase 2 trials. These results highlight the potential efficacy of CYB003 as a transformative option for individuals suffering from MDD.

In November 2024, Cybin initiated the PARADIGM™ program, a pivotal multinational Phase 3 study aimed at further evaluating the efficacy and safety of CYB003. This robust clinical trial will contribute valuable data to the ongoing development of the drug and further establish its role in the mental health treatment landscape.

In addition to CYB003, Cybin is also developing CYB004, a deuterated N, N-dimethyltryptamine molecule that is currently in Phase 2 trials for generalized anxiety disorder. The company is focused on revolutionizing mental healthcare by creating innovative treatment options for various mental health conditions, expanding the landscape of available therapies.

Founded in 2019, Cybin operates globally, with established presences in Canada, the United States, the United Kingdom, the Netherlands, and Ireland. This international reach enables Cybin to engage with a wide range of markets and patient populations, enhancing its ability to meet diverse mental healthcare needs.

The collaboration with Thermo Fisher represents a significant step forward for Cybin in its mission to address the unmet needs in mental health treatment. By harnessing advanced manufacturing capabilities and focused development strategies, Cybin aims to provide innovative solutions for patients suffering from Major Depressive Disorder and other psychiatric conditions.

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• Business Wire
• Wikipedia: Major Depressive Disorder
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• Encyclopedia Britannica: Depression (Mental Disorder)
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