Cybin’s Recent Depression Research Reveals 71% Rate of Remission

Cybin’s Recent Depression Research Reveals 71% Rate of Remission

Cybin’s Recent Depression Research Reveals 71% Rate of Remission

Cybin has announced a remarkable 71% remission rate among individuals diagnosed with major depressive disorder (MDD) who underwent a treatment regimen with two doses of psilocin therapy, known as CYB003, during a Phase II clinical trial.

This therapy significantly mitigated the severity of MDD, demonstrated by a 23-point decrease on the Montgomery-Asberg Depression Rating Scale (MADRS) when evaluated at the 12-month mark.

The stock value of Toronto-based Cybin surged by 14% following the news, bringing shares to .25 each as the trading session commenced on Monday.

CYB003 contains psilocin, a substance akin to certain neurotransmitters like serotonin. The FDA has awarded it a breakthrough designation as an adjunctive treatment for MDD. Cybin promoted these findings as an endorsement of the dosing strategy, asserting that CYB003 shows a strong, lasting effect and potential for prolonged relief from symptoms.

However, the study included a limited participant pool, with only eight patients from the 16-mg group reaching the 12-month follow-up, and just seven of them receiving the complete two-dose treatment. Notably, every participant responded positively to the therapy, resulting in a 71% remission rate. The two individuals who did not achieve remission fell marginally short of the MADRS score necessary for classification as in remission, as indicated by Cybin.

In the 12-mg cohort, Cybin recorded an 18-point MADRS score reduction, with 60% of patients showing a response and half achieving remission. Remarkably, there were no reported adverse events.

Recently, Cybin initiated a Phase III clinical program for CYB003 as a complementary treatment for MDD, with topline results anticipated in 2026.

The neuropsychiatry field is known for its significant challenges, with many companies struggling to transition early successes into Phase III triumphs. Sage Therapeutics recently abandoned its MDD indication for Zurzuvae, which the FDA had approved for postpartum depression but not the more prevalent MDD in August 2023.

Alto Neuroscience faced a setback when its MDD therapy ALTO-100 failed in a Phase IIb trial, merely nine months following its public offering. William Blair highlighted that “placebo-controlled MDD studies have historically been high-risk.” Alto has another MDD trial with expected results in 2025 for ALTO-300, which already holds approval for depression treatment in Europe and Australia.

Cybin is navigating a challenging landscape in psychedelics, particularly after the FDA’s August 2024 rejection of Lykos regarding its MDMA-assisted therapy for PTSD. However, Cybin’s CEO Doug Drysdale mentioned that the feedback from the FDA could prove beneficial for developers in the psychedelics sector.

“It’s actually in some ways helpful to have all this feedback from the adcomm and from the FDA because we can incorporate that into our programs ahead of time.”