Cyclerion Therapeutics Announces Positive Topline Clinical Data for CY6463 in Patients with Cognitive Impairment Associated with Schizophrenia (CIAS)

Study data demonstrate positive effects of CY6463 on cognition and inflammation after two weeks of dosing in patients with stable schizophrenia on standard of care

Oral, once-daily CY6463 was well tolerated, with no reports of serious adverse events (SAEs) or treatment discontinuation due to adverse events (AEs)

Data demonstrate the translation of sGC multi-dimensional pharmacology and the therapeutic potential of amplifying sGC signaling in the CNS and support the further development of oral, once-daily CY6463

Excerpt from the Press Release:

CAMBRIDGE, Mass., July 28, 2022 (GLOBE NEWSWIRE) — Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, today announced positive topline data from its clinical study of CY6463 for the treatment of Cognitive Impairment Associated with Schizophrenia (CIAS) in individuals with stable schizophrenia on a stable, single, atypical antipsychotic regimen. Data from the 14-day, double-blind, randomized, placebo-controlled, multiple-ascending-dose study demonstrate that once-daily CY6463 was safe and well tolerated, with no reports of serious adverse events (SAEs), severe adverse events (AEs), or treatment discontinuation due to AEs. Study data demonstrate a strong effect on cognitive performance after two weeks of 15mg once-daily dosing. A broad positive movement on inflammatory biomarkers was also observed. These signals on exploratory endpoints provide further evidence of the pro-cognitive and anti-inflammatory effects of CY6463 observed in preclinical studies and prior clinical trials.

“Cognitive impairment is a central debilitating, and untreated facet of schizophrenia, and there is a significant need for a treatment option that improves cognition,” said Steven E. Hyman, M.D., Core Member of the Broad Institute, Director of the Stanley Center for Psychiatric Research at the Broad Institute, and new member of Cyclerion’s Board of Directors. “I am encouraged by the promising cognition signals observed after only two weeks of CY6463 dosing in patients with stable schizophrenia. These data demonstrate the therapeutic potential of amplifying sGC signaling in the CNS, including positive effects on cognition and inflammation, and support further development of CY6463 in diseases characterized by cognitive impairment.”

CY6463 is a positive allosteric modulator of soluble guanylate cyclase (sGC) that amplifies endogenous nitric oxide (NO) signaling, a pathway that has been linked to schizophrenia.

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