Cybin reports CYB003 demonstrated reduction in symptoms of depression

Cybin announced Phase 2 interim results for CYB003, its proprietary deuterated psilocybin analog, demonstrating a statistically significant reduction in symptoms of depression three weeks following a single 12mg dose compared to placebo. At the three-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. Generally, values less than 0.05 are considered statistically significant and values less than0.001 are considered highly statistically significant. The Phase 2 clinical trial is evaluating efficacy using the MADRS scale, with a primary efficacy endpoint of reduction in depression symptoms at week 3 after a single administration. To date, dosing has been completed in all dose cohorts up to 16mg, with a favorable safety and tolerability profile and no treatment-related serious adverse events observed. Interim results from the 12mg dose cohort have demonstrated a statistically significant and clinically meaningful reduction in symptoms of depression with a single dose at three weeks after treatment. The MADRS is a 10-item, clinician-administered scale designed to measure overall severity of depressive symptoms in subjects with MDD. It is widely used in clinical trials and accepted by regulatory authorities worldwide as a measure of symptoms of depression. The MADRS includes items ranging from sadness of mood, reduction in sleep and appetite, to difficulties in concentration, anhedonia, and negative and suicidal thoughts that are scored from 0 to 6 giving a total score ranging from 0 to 60. Typical score ranges for severity are: 0-6 normal; 7-19 mild; 20-34 moderate; and greater than34 severe depression. In the CYB003 study, mean baseline total scores on the MADRS were 32.6 and 33.3 in the active and placebo groups, respectively. Rapid and statistically significant improvements in depression symptoms observed after single doses of CYB003: Improvements in depression symptoms evident on the day after dosing, reaching a peak 10 days after dosing, and maintained thereafter. Robust and statistically significant reduction in depression symptoms compared to placebo at 3 weeks, with a -14.08 difference in change from baseline in MADRS for CYB003 vs. placebo. Robust response rates at three weeks after single dose: 53.3% response rate for CYB003 vs. 0% for placebo, 20.0% remission rate for CYB003 vs. 0% for placebo. CYB003 was well tolerated with no drug-related Serious Adverse Events. All Adverse Events were mild or moderate in intensity and resolved spontaneously without intervention. Full topline safety and efficacy data from the CYB003 MDD study is expected by the end Q4 2023, with 12-week durability data anticipated in Q1 2024. Cybin plans to submit this topline data to the FDA and request an end of Phase 2 meeting to be held in Q1 2024. Recruiting for a CYB003 Phase 3 study is anticipated to begin by the end of Q1 2024. The company also expects to share topline Phase 1 data for CYB004 and SPL028, its proprietary novel deuterated N,N-dimethyltryptamine compounds, before the end of 2023, supporting the initiation of a Phase 2 study in participants with generalized anxiety disorder in Q1 2024.