Cybin Inc. Releases Interim Findings for Its Innovative Psilocybin Analog, CYB003

LOS ANGELES- In a major step for mental health treatment innovation, Cybin Inc. today publicized the interim results of its Phase 2 clinical trial for CYB003, its proprietary deuterated psilocybin analog. These findings highlight a robust and statistically substantial decrease in depressive symptoms as early as three weeks post a single 12mg dosage, a remarkable outcome when contrasted with a placebo.

The study’s architecture centered around gauging efficacy, especially focusing on the alleviation of depressive symptoms three weeks after administering the dose. The Montgomery–Åsberg Depression Rating Scale (MADRS) was the chosen tool for this evaluation—a ten-item clinician-administered measure employed widely for its accuracy in gauging depressive symptoms. MADRS, which enjoys worldwide endorsement from regulatory bodies, evaluates aspects including mood fluctuations, appetite and sleep alterations, concentration lapses, among other parameters.

Participants in the CYB003 trial, on average, started with MADRS scores of 32.6 and 33.3 for the active and placebo groups, respectively.

Striking Outcomes from CYB003 Study

The analysis, when observed at its primary efficacy juncture, three weeks in for Major Depressive Disorder (MDD) symptoms, revealed a significant 14.08-point distinction between the control and the treated group (p=0.0005, Cohen’s d=2.15). It’s essential to note the importance of a p-value under 0.05, indicating statistical significance. Furthermore, values south of 0.001 denote high statistical relevance.

Additionally, the CYB003 group showcased a profound 53.3% response rate, signaling a reduction in MADRS scores by more than half, while the placebo contingent stood at a 0% response rate.

Equally impressive, 20% of participants treated with CYB003 went into remission, recording MADRS scores under 10. In contrast, the placebo group witnessed no such remission.

In light of these findings, Cybin’s CEO, Doug Drysdale, conveyed his hopeful stance for both medical practitioners and patients alike. He accentuated the superior performance of CYB003 against prevailing depression treatments. The community keenly awaits the full topline data, projected for release later this quarter, with 12-week persistence data scheduled for the first quarter of 2024.

As Cybin sets its eyes on a global Phase 3 trial at the dawn of 2024, the emphasis remains on CYB003’s safety and efficacy in treating MDD.

On the Horizon for Cybin

Cybin’s trajectory, as per the company’s projections, includes unveiling the full topline safety and efficacy data from the CYB003 MDD study by the close of Q4 2023. By Q1 2024, we can expect the 12-week persistence data. Concurrently, the firm intends to present this data to the FDA, seeking an end-of-Phase 2 consultation early in 2024. Recruitment initiatives for the subsequent Phase 3 study of CYB003 are projected to kick off by the culmination of Q1 2024.

Moreover, Cybin is on track to reveal topline Phase 1 findings for CYB004 and SPL028, its proprietary novel deuterated N,N-dimethyltryptamine (DMT) compounds, by the year-end. This is a precursor to the commencement of a Phase 2 study for individuals grappling with generalized anxiety disorder in early 2024.