Cybin: CYB003 Achieves ‘Primary Efficacy Endpoint’ in Phase 2 Study

“Frankly, I see these results as the biggest breakthrough in psychiatric pharmacology in the last 40 years,” CEO Doug Drysdale said.

Cybin on Nov. 30 reported positive top-line data from the Phase 2 study of its proprietary deuterated psilocybin analog for treatment of major depressive disorder.

In a news release, Cybin CEO Doug Drysdale said CYB003 “achieved the primary efficacy endpoint in this study and showed rapid and statistically significant improvements in depression symptoms after a single dose, with a clear incremental benefit of a second dose, resulting in four out of five patients in remission from their depression at six weeks.”

On the heels of the interim Phase 2 results announced earlier in November, Drysdale asserted that “the strength of the data supports progression to a Phase 3 study of CYB003 for the treatment of MDD.”

During a briefing with investors and analysts in New York City, Drysdale called the Phase 2 data “overwhelmingly positive.”

“The findings … are certainly significant for Cybin, but they’re also significant in terms of progressing the whole mental health sector,” he said. “Frankly, I see these results as the biggest breakthrough in psychiatric pharmacology in the last 40 years. It has the potential to transform the way we treat mental illness and improve patient outcomes.”

Amir Inamdar, chief medical officer for Toronto-based Cybin, said the results are “highly gratifying.”

“At the three-week primary efficacy endpoint, a single 12-mg dose of CYB003 showed a rapid, robust and highly statistically significant improvement in depression symptoms compared to placebo, with a -14.08 point difference in change from baseline in MADRS (p=0.0005, Cohen’s d=2.15),” Inamdar explained in a news release. “This translated into a very large effect size. Similar significant and robust effects were also seen with a single 16-mg dose, which resulted in an improvement in symptoms of depression as measured using the MADRS total score by about 13 points versus placebo.”

The positive effects of CYB003 “were evident on Day 1 with the 16-mg dose and were also highly statistically significant,” he added.

“When data from 12 mg and 16 mg are pooled, these robust effects are maintained. Further, with two doses, response and remission rates in excess of 75% were observed with CYB003 (12 mg). With these findings in hand, we are encouraged by the potential of CYB003 to help those with MDD and look forward to progressing to a multinational, multisite Phase 3 study early next year.”

Cybin plans to submit the top-line data to the U.S. Food and Drug Administration and request an end-of-Phase 2 meeting to be held in Q1 2024. Additional 12-week durability data from the Phase 2 CYB003 study is anticipated in Q1 2024.

The company said it expect to begin recruiting for a CYB003 Phase 3 study by the end of Q1 2024.