Cyclerion receives FDA feedback on depression treatment study

Cyclerion Therapeutics (NASDAQ: CYCN) received positive written feedback from the U.S. Food and Drug Administration regarding its planned Phase 2 proof-of-concept study for CYC-126, an investigational therapy for treatment-resistant depression.

The FDA provided guidance on CYC-126's regulatory pathway and supported the company's proposed study design. CYC-126 combines anesthetic agents with real-time electroencephalogram monitoring and algorithm-guided dosing. The treatment will be regulated under the FDA's Center for Drug Evaluation and Research, with input from the Center for Devices and Radiologic Health.

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia. Participants will be randomized to either active treatment or sham control groups to assess safety, efficacy and durability of response using the Montgomery–Åsberg Depression Rating Scale.

Cyclerion remains on track to initiate the Phase 2 study in the second half of 2026, with the first patient enrollment in Australia and U.S. enrollment beginning in the first half of 2027.

The Cambridge, Massachusetts-based biopharmaceutical company also formed a Clinical Advisory Board with five members, including Dr. Husseini Manji, a former Global Head of Neuroscience at Janssen/Johnson & Johnson, and Dr. Linda Carpenter, Professor of Psychiatry at Brown University's Alpert Medical School.

The company has selected a contract research organization to support the multinational study execution. Information is based on a company press release.

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