Positive top-line statistics from Cyclerion Therapeutics’ clinical investigation of CY6463 for the treatment of cognitive impairment associated with schizophrenia have been released. It concerns people with stable schizophrenia who are taking a stable dose of a single atypical antipsychotic drug.
In order to increase endogenous nitric oxide signalling, CY6463 acts as a positive allosteric modulator of soluble guanylate cyclase, a route that has been connected to schizophrenia.
48 individuals with stable schizophrenia participated in the clinical trial. The once-daily CY6463 was safe and well tolerated, with no reports of significant adverse events, severe adverse events, or treatment discontinuation, according to findings from a 14-day, double-blind, placebo-controlled, multiple-ascending-dose study.
In addition, the trial data showed a significant improvement in cognitive function after two weeks of taking 15 mg once a day, as well as a significant improvement in inflammatory biomarkers. The pro-cognitive and anti-inflammatory impacts of CY6463 seen in preclinical research and earlier clinical trials are further supported by these signals on exploratory endpoints.
There is a great need for a therapy option that improves cognition, said the head of the Stanley Center for Psychiatric Research at the Broad Institute, Steven Hyman. Cognitive impairment is a fundamental, debilitating, and untreated, component of schizophrenia. He said he was impressed by the encouraging cognition signals seen in patients with stable schizophrenia after just two weeks of CY6463 dosing. This finding supports the further advancement of CY6463 in conditions marked by cognitive impairment by showing its beneficial effects on inflammation and cognition.
According to chief scientific officer at Cyclerion Therapeutics, Andreas Busch, this is the second clinical study effectively proving safety, pharmacokinetics, and therapeutic effectiveness in a patient population where prior medication development has been exceedingly problematic.
These encouraging results contribute to a substantial body of evidence supporting the development of CY6463 in CNS disorders where cognition is affected, such as CIAS and MELAS. They support earlier clinical and preclinical findings. They are keen to capitalise on the momentum created by this encouraging data and are still looking for ways to speed up development, improve patient selection, and enhance endpoint evaluation.