TORONTO - Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN), a clinical-stage biopharmaceutical company, has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its investigational drug CYB003, a deuterated psilocybin analog developed for major depressive disorder (MDD). This designation, the first for an adjunctive psychedelic-based therapy for MDD, could significantly reduce the timeline for the drug's development.
The company's recent Phase 2 trial results showed a substantial and sustained improvement in depression symptoms four months post-treatment, with 75% of subjects in remission after two 16mg doses of CYB003. These findings support the advancement of CYB003 into a pivotal Phase 3 multinational study, expected to commence in mid-2024.
BTD is granted to drugs that may offer substantial improvements over existing therapies for serious conditions. It includes features of the FDA's fast track program and provides increased FDA guidance, potentially expediting CYB003's development and review process. Cybin's CEO, Doug Drysdale, expressed gratitude for the designation, anticipating a streamlined path towards new drug approval.
The Phase 2 trial data revealed a mean 22-point reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline at four months, indicating a significant improvement in depression symptoms. Safety and tolerability data showed no serious drug-related adverse events, further supporting the drug's development.
The BTD underscores the urgent need for new treatments for MDD, a condition affecting over 300 million people worldwide. Existing treatments, such as selective serotonin reuptake inhibitors (SSRIs), often do not lead to remission in patients with depression. Cybin aims to address this gap with CYB003, potentially offering a new treatment paradigm with intermittent dosing.
Cybin is set to host a webcast today at 8:30 a.m. ET to discuss the CYB003 program updates. The webcast will provide further insights into the company's development strategy and the upcoming Phase 3 trial.
This article is based on a press release statement from Cybin Inc. and does not constitute an endorsement of the company or its products. The information presented is for informational purposes only and reflects the company's current expectations and projections.
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