Company reported “overwhelmingly positive” results three weeks after initial dose.
Participants in Cybin Inc.’s Phase 2 psilocybin trial experienced significant reduction in depressive symptoms after taking a single 12-milligram dose of the psilocybin analog, the company reported.
Cybin said participants in its Phase 2 psilocybin trial reported a notable decrease in depressive symptoms three weeks following the administration of a 12-milligram dose of the drug.
Study participants receiving a 12-milligram dose of Cybin’s CYB003 psilocybin analog experienced a “rapid, robust and statistically significant reduction” in depression symptoms, Cybin reported on Oct. 31.
“The overwhelmingly positive interim results for the 12-milligram dose of CYB003 are extremely encouraging for patients and providers,” Cybin CEO Doug Drysdale said in a news release. “The efficacy demonstrated at that dosage showed an unprecedented reduction in depressive symptoms compared to currently available treatments.”
The company expects to share the full results of the study later in the year and 12-week durability data in the first quarter of 2024, Drysdale said.
“Our planning continues as we prepare for a larger international, multisite Phase 3 trial in early 2024 to further evaluate the safety and efficacy of CYB003 in people suffering from MDD (major depressive disorder),” he said.
The study revealed a notable decrease in Major Depressive Disorder (MDD) symptoms, measured by the change in the Montgomery–Åsberg Depression Rating Scale, or MADRS, total score. The MADRS is a 10-item, clinician-administered scale designed to measure overall severity of depressive symptoms in subjects with MDD.
Participants who were given CYB003 showed a superior reduction in symptoms compared to those who received a placebo by 14.08 points (p=0.0005, Cohen’s d=2.15). A p-value below 0.05 is considered statistically significant, and values below 0.001 are regarded as highly statistically significant.
In this Phase 2 clinical trial, the efficacy of CYB003 is being assessed using the MADRS scale, focusing on the reduction in depression symptoms three weeks after a single administration. All dose cohorts, up to 16 milligrams, have undergone dosing, demonstrating a favorable safety and tolerability profile with no treatment-related serious adverse events observed.
Cybin also said it expects to share topline Phase 1 data for CYB004 and SPL028, its novel deuterated N,N-dimethyltryptamine (DMT) compounds, before the end of 2023, supporting the initiation of a Phase 2 study in participants with generalized anxiety disorder in Q1 2024.