Cyclerion Therapeutics Announces Progress Toward CYC-126 Phase 2 Proof-of-Concept Study with FDA Feedback and Formation of Clinical Advisory Board

Core Insights - Cyclerion Therapeutics has received positive written feedback from the FDA regarding its CYC-126 Phase 2 Proof-of-Concept study for Treatment Resistant Depression (TRD) [1][3] - The company is on track to initiate the Phase 2 study in the second half of 2026, with patient enrollment beginning in Australia and the U.S. in 2027 [3][7] - A Clinical Advisory Board has been formed, consisting of key leaders in neuropsychiatry and anesthesiology to guide the development of CYC-126 [4][5] FDA Feedback and Study Design - The FDA provided clear guidance that supports the advancement of CYC-126's Phase 2 study design, which will utilize FDA-approved anesthetics and established safety data [3] - The planned study will be a randomized, double-blind, two-part clinical trial assessing safety, antidepressant efficacy, and durability of response using the Montgomery–Åsberg Depression Rating Scale (MADRS) [2] Clinical Advisory Board - The Clinical Advisory Board includes five internationally recognized experts in neuropsychiatry and anesthesiology, who will provide strategic guidance for CYC-126's development [4][5] - Notable members include Dr. Husseini Manji, Dr. Linda Carpenter, Dr. Lawrence Olanoff, Dr. Yuriy Bronshteyn, and Dr. Laeben C. Lester, each bringing extensive experience in their respective fields [6] Company Overview - Cyclerion is focused on developing treatments for neuropsychiatric diseases, with CYC-126 positioned as a cornerstone for future growth, addressing a significant unmet medical need in TRD [8]