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Cyclerion Announces CY6463 Clinical Pipeline Progress and First Quarter 2022 Financial Results
Characterizing the novel neuropharmacology of CY6463’s NO-sGC-cGMP signal modulation in an integrated clinical strategy currently involving three ongoing,
About this update from Cyclerion Therapeutics, Inc.
[{"type":"text","content":"Characterizing the novel neuropharmacology of CY6463’s NO-sGC-cGMP signal modulation in an integrated clinical strategy currently involving three ongoing, exploratory, biomarker-rich, signal seeking studies: Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes (MELAS) study enrollment closed; topline data expected in Q2 2022Cognitive Impairment Associated with Schizophrenia (CIAS) study enrollment closed; topline data expected in Q3 2022Alzheimer’s Disease with vascular pathology (ADv) study enrollment ongoing CAMBRIDGE, Mass., May 04, 2022 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, announced today clinical development progress for CY6463, its lead program, and first quarter 2022 financial results. “We are building on three previously reported clinical studies that demonstrated a favorable safety and tolerability profile for CY6463 with exposure in the brain that led to neurophysiology changes associated with cognition, by continuing to characterize the novel neuropharmacology of NO-sGC-cGMP signal modulation and advancing CY6463 toward data readouts in three exploratory clinical studies in CNS diseases associated with cognitive impairment.” said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion Therapeutics. “We have recently closed enrollment on our CY6463 studies in MELAS and CIAS and look forward to obtaining topline clinical data from these exploratory studies in Q2 and Q3 2022, respectively. We expect that these pending data may provide further evidence supporting the optimal clinical utility for our most advanced CNS penetrant sGC stimulator and refine our plans for further development efforts, including dose and patient selection, and study endpoints. We have also continued to enroll our CY6463 study in Alzheimer’s Disease with vascular pathology, while efficiently driving Cyclerion’s earlier stage research programs forward.” Clinical Pipeline Updates Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes (MELAS) The MELAS trial (NCT04475549) is an open-label, single-arm study of oral, once-daily CY6463 in adults aged 18 or older with MELAS. The study includes measures of safety, tolerability, pharmacokinetics, and exploratory pharmacodynamic...