Study demonstrates long-term remission potential in depression treatment.
Cybin Inc. reported 100% patient response rates in its Phase 2 clinical study of CYB003, a psilocybin-based therapy for major depressive disorder (MDD), with FDA Breakthrough Therapy Designation.
The study found patients achieved a 100% response rate at 12 months using two 16 mg doses administered three weeks apart. Seventy-one percent of participants remained in remission at the 12-month mark, with a mean improvement of nearly 23 points on the MADRS total score.
Current antidepressants fail to achieve remission in up to two-thirds of MDD patients, according to Cybin.
CEO Doug Drysdale characterized the results as a potential shift from managing MDD symptoms to potentially changing the disease’s progression.
“Our Phase 2 study results are remarkable and validate both our intermittent dosing regimen, as well as CYB003’s potential to revolutionize the current standard of care in MDD,” he said. “We are quite possibly witnessing a watershed moment in mental health care treatment paradigms and practices.”