- Cybin Inc. (CYBN, Financial) announces strategic clinical partnerships for its Phase 3 program evaluating CYB003.
- The study aims to include approximately 45 clinical sites, with 18 sites already secured through agreements.
- Phase 2 results showed 71% remission in MDD patients, with Phase 3 studies underway.
Cybin Inc. (CYBN), a leader in neuropsychiatry, has announced additional strategic clinical site partnerships, enhancing its multinational Phase 3 program to evaluate CYB003 for the treatment of Major Depressive Disorder (MDD). These partnerships increase the total engaged clinical sites to 18, with a target of approximately 45 sites for the APPROACH study.
Doug Drysdale, CEO of Cybin, emphasized the importance of these Strategic Partnership Agreements (SPAs) in streamlining trial operations and improving patient recruitment. The SPAs are designed to leverage site expertise, ensuring consistent application of protocols and best practices, potentially reducing the trial completion timeline.
The Phase 2 study results were promising, with 71% of MDD patients achieving symptom remission for 12 months after receiving two 16 mg doses of CYB003, administered three weeks apart. The company is proceeding with patient dosing in its first pivotal Phase 3 study, APPROACH, and plans to initiate a second Phase 3 study, EMBRACE, by mid-2025.
Strategic partners, including Kimball A. Johnson, M.D., of CenExel iResearch Atlanta and Paul Thielking, Chief Scientific Officer of Cedar Clinical Research, have joined the program to support the trial's advancement. Their collaboration underlines a commitment to developing safe, effective next-generation treatments for mental health conditions.
Founded in 2019, Cybin operates in Canada, the United States, the United Kingdom, the Netherlands, and Ireland. The company focuses on innovative treatments to meet the significant unmet needs in mental healthcare, leveraging its research on deuterated psilocin and 5-HT receptor-focused compounds.
