Cybin's Clinical Milestones and Recent Positive Trial Results

Cybin Inc., a biopharmaceutical firm specializing in psychedelic-based treatments, has shared encouraging Phase 2 results for its CYB003 drug candidate, which is aimed at treating Major Depressive Disorder (MDD). The study demonstrated significant improvements in depressive symptoms with a high remission rate of 79% after two doses of the drug. This positive outcome positions the company to move forward with a multinational Phase 3 trial in early 2024, which is supported by an extensive intellectual property portfolio, including granted patents and pending applications.
Cybin's CYB003, a deuterated psilocybin analog, has shown rapid and substantial symptom relief in patients with moderate to severe MDD. The drug's efficacy was measured using the Montgomery–Asberg Depression Rating Scale (MADRS), where a mean difference of -13.75 points between the drug and placebo was observed, indicating a statistically significant improvement at three weeks. The drug also exhibited a superior effect size compared to currently approved antidepressants, with a Cohen’s d greater than 2, compared to 0.243 for selective serotonin reuptake inhibitors (SSRIs).
The company's DMT program, featuring CYB004 and SPL028, is also advancing, with the potential for less invasive dosing methods. CYB004 is protected by a U.S. composition of matter patent that could extend coverage until 2041. Cybin has successfully completed several clinical trials for its DMT/dDMT assets, including a Phase 2a trial for SPL026, which showed a significant reduction in depression symptoms and a durable antidepressant response at six months.
Upcoming milestones for Cybin include the release of additional Phase 2 data for CYB003 in the first quarter of 2024, an FDA end-of-Phase 2 meeting, and the initiation of a Phase 3 trial for CYB003 in MDD. For the DMT program, Phase 1 data for CYB004 and SPL028 are expected early in the first quarter of 2024, and a Phase 2 Generalized Anxiety Disorder (GAD) study is planned for the same period.
Cybin, founded in 2019 and headquartered in Canada, is operational across several countries, including the United States, the United Kingdom, the Netherlands, and Ireland. The company is dedicated to developing innovative treatments for mental health conditions and is backed by a network of partners and scientists focused on drug discovery and delivery systems. Cybin's efforts are aimed at transforming mental healthcare and offering new hope for patients and healthcare providers through its research pipeline of psychedelic-based compounds.