Cybin Inc. (CYBN) announced Phase 2 interim results for CYB003, its proprietary deuterated psilocybin analog, demonstrating a rapid, robust and statistically significant reduction in symptoms of depression three weeks following a single 12mg dose compared to placebo.
In Tuesdsay pre-market trading, CYBN was trading at $0.65 up $0.04 or 8.18%.
At the 3-week primary efficacy endpoint, the reduction in major depressive disorder or "MDD" symptoms, defined as change from baseline in MADRS total score, was superior in participants assigned to CYB003 compared to the participants who received placebo by 14.08 points. A p-value indicates statistical significance.
The company said it looks forward to sharing the full complement of topline data later this quarter, and 12-week durability data in the first quarter of 2024. The company is preparing for a larger international, multisite Phase 3 trial in early 2024 to further evaluate the safety and efficacy of CYB003 in people suffering from MDD.
The company plans to request an end of Phase 2 meeting with the FDA in early 2024 to align on Phase 3 trial design, and the company is commencing dosing with a capsule formulation of CYB003 in the bioequivalence cohort and further manufacturing of GMP materials that will be dose flexible, patient friendly and commercially scalable.
For More Such Health News, visit rttnews.com
For comments and feedback contact: editorial@rttnews.com
Business News
April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.