By All Stocks News
Cybin Inc., a leading biopharmaceutical company focused on advancing mental healthcare through innovative psychedelic treatments, has unveiled promising Phase 2 interim results for CYB003, its proprietary deuterated psilocybin analog. In this clinical trial, a single 12mg dose of CYB003 demonstrated a rapid and statistically significant reduction in depression symptoms compared to a placebo, with a remarkable reduction of 14.08 points in major depressive disorder (“MDD”) symptoms measured by the MADRS scale at the 3-week primary efficacy endpoint (p=0.0005, Cohen’s d=2.15).
These results are being hailed as highly encouraging by Doug Drysdale, Cybin’s CEO, who noted that the efficacy observed at this dosage level surpassed currently available treatments. The company plans to release full topline data later in the quarter, with 12-week durability data anticipated in Q1 2024. Cybin is also preparing for a larger Phase 3 trial, set to begin in early 2024, to further assess the safety and effectiveness of CYB003 in MDD patients.
The Phase 2 trial evaluated the efficacy of CYB003 using the MADRS scale, measuring the reduction in depression symptoms three weeks after a single administration. Importantly, all dose cohorts up to 16mg exhibited a favorable safety profile with no serious treatment-related adverse events. The rapid onset of antidepressant effects was observed within a day after dosing, peaking at 10 days, and maintained thereafter.
Cybin’s Chief Medical Officer, Amir Inamdar, highlighted the potential for CYB003 to address a wide range of mental health conditions, given the positive interim results and emerging data from academic studies.
In the near future, Cybin aims to share Phase 1 data for CYB004 and SPL028, their proprietary novel deuterated N,N-dimethyltryptamine (“DMT”) compounds, supporting the initiation of a Phase 2 study for generalized anxiety disorder in Q1 2024.
Additionally, a conference call and webcast to discuss these developments is scheduled for November 1, 2023, providing further insight into Cybin’s progress in the field of psychedelic medicine.