Psilocybin analog reduces depression symptoms after one dose in phase 2 trial

A single dose of Cybin Inc.’s CYB003, an investigational deuterated psilocybin analog, resulted in statistically significant improvement in depression symptoms after 3 weeks compared with placebo, the company announced in a press release.

According to interim phase 2 trial data, there was a mean 14-point decrease from baseline in Montgomery-Asberg Depression Rating Scale scores at 3 weeks among participants with major depressive disorder who received one 12 mg dose of CYB003 compared with placebo. Comparatively, data from current studies demonstrate that selective serotonin reuptake inhibitors yield an average improvement of 1.82 points vs. placebo, the release stated.

Further, the company reported that more than half (53.3%) of participants on CYB003 responded to a single dose and 20% no longer met the clinical definition of depression, compared with 0% on placebo.

“The overwhelmingly positive interim results for the 12 mg dose of CYB003 are extremely encouraging for patients and providers,” Doug Drysdale, Cybin’s CEO, said in the release. “The efficacy demonstrated at that dosage showed an unprecedented reduction in depressive symptoms compared to currently available treatments.”

The company also reported that CYB003 was well-tolerated with no serious treatment-related adverse events at the 12 mg dose. Adverse events were mild or moderate and resolved without intervention.

“With these encouraging results in hand, we look forward to sharing the full complement of topline data later this quarter and 12-week durability data in the first quarter of 2024,” Drysdale said in the release.

Cybin plans to conduct a larger international, multisite phase 3 trial of CYB003 in early 2024, the release stated.