71% of Patients in Cybin’s Small Depression Study Are in Remission

The Canada-based biotechnology company Cybin has announced the results of a Phase II study of the psilocin treatment CYB003 for major depressive disorder, claiming a 71% remission rate for patients who received two doses of the treatment.

The therapy also decreased the expressiveness of the disorder in the MADRS, which dropped 23 points from baseline at 12 months.

CYB003 is a psilocin, a type of molecule resembling neurotransmitters like serotonin in its structure, at least. The therapy has been assigned a breakthrough therapy designation by the FDA as an adjunctive therapy for MDD. The company said this highlighted the dosing regimen of CYB003 as well as reiterated that the medicine was highly durable and, therefore, had the propensity to offer sustained relief.

However, patient enrollment was limited, with only eight patients completing follow-up at 12 months in the cohort receiving 16 mg and only seven of those receiving both doses. Every one of the above patients benefited from the therapy, and 71% of these patients had remission. The two patients who took two doses, though they were not in remission, exhibited a MADRS score zigzag only two points below the midpoint to be considered in remission, according to Cybin.

From the 12-mg group, Cybin achieved a reduction of 18 in the MADRS score, with 60% of the patients afforded the response, and half of them reaching a state of remission. There were no adverse events.

CYB003 last week was initiated into a Phase III program as an adjunctive treatment for MDD. Effectiveness data from the program are expected to be out in 2026.

Neuropsychiatry as a disease area tends to have its roots in the past, as many firms struggle to turn early-stage results into success in Phase III trials. Last year, Sage Therapeutics recently lost an MDD indication for Zurzuvae that was approved by the FDA for postpartum depression but not the more prevalent MDD in August 2023.

In October, the company’s MDD drug candidate ALTO-100 was terminated in a Phase IIb trial, only nine months after the firm’s IPO. Alto has another MDD readout planned for 2025 with ALTO-300, which is cleared for depression in Europe and Australia.

Cybin also operates in a volatile psychedelics market, which witnessed the August 2024 rejection of Lykos’ PTSD treatment based on MDMA by the FDA. But the guidance that the agency offers with its rejection could help psychedelics developers, according to the company.

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