Cyclerion Therapeutics Announces Initiation of Patient Dosing in CY6463 Phase 2a Study in Alzheimer’s Disease with Vascular Pathology

Study to evaluate safety, tolerability, pharmacokinetics, and potential to improve cognition

Excerpt from the Press Release:

CAMBRIDGE, Mass., Jan. 26, 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 that patient dosing has begun in its Phase 2a study in Alzheimer’s Disease with Vascular Pathology (ADv).

“The need for effective new treatments for Alzheimer’s disease is immense, and, given the aging population demographics and increasing rate of diagnosis, this need will continue to expand. We believe that CY6463 has potential to provide meaningful cognitive benefits and are very pleased to have initiated this important clinical study,” said Andreas Busch, Ph.D., Chief Scientific Officer of Cyclerion. “Our CY6463 ADv development efforts are supported by preclinical data which demonstrate beneficial effects on cognition measures and the neuronal and microglia cellular activity thought to have a central role in the pathology and the cognitive dysfunction experienced by individuals living with ADv. Furthermore, a Phase 1 study in elderly subjects demonstrated an impact on biomarkers relevant to neurodegeneration and cognitive impairment. The ongoing Phase 2a study will focus on a segment of the Alzheimer’s disease population where we believe our therapeutic candidate has the best opportunity to provide a clinical benefit. We expect this trial to deliver a rich dataset that will deepen our understanding of the therapeutic potential of CY6463 and will enable well-informed decisions regarding further development.”

The Phase 2a ADv study (NCT04798989) is a randomized, placebo-controlled study of oral once-daily CY6463 in approximately 30 participants over a twelve-week dosing period. Study participants must have confirmed Alzheimer’s disease pathology as assessed by PET or CSF biomarkers, cardiovascular risk factors, as well as mild-to-moderate subcortical small-vessel disease as assessed by MRI. The study will evaluate safety, tolerability, and pharmacokinetics as well as explore the impact on various disease-relevant pharmacodynamic biomarkers (e.g., EEG, MRI, neuroinflammatory biomarkers) and cognitive performance.

Click the button below to read the entire Press Release:

Continue Reading The Press Release