announced top-line results from the of olinciguat for the potential treatment of sickle cell disease (SCD). Results did not demonstrate adequate activity to support further internal clinical development. Olinciguat was generally well tolerated across all dose ranges. Cyclerion intends to complete its analysis of the study results and present or publish them in a future forum.
The STRONG-SCD study was a randomized, placebo-controlled, dose-ranging study of 70 patients designed to evaluate safety, tolerability, and pharmacokinetics of olinciguat, compared to placebo, as well as to explore effects on daily symptoms and biomarkers of disease activity when dosed over a 12-week treatment period.
Cyclerion simultaneously from a phase 1 study of IW-6463, the first soluble guanylate cyclase (sGC) stimulator in clinical development for CNS disorders. Based on this data, Cyclerion plans to focus its resources on upcoming Phase 2 clinical trials in Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes (MELAS) and Alzheimerâ€™s disease with vascular pathology (ADv).
Olinciguat is an orally administered, once-daily, vascular sGC stimulator designed for the treatment of sickle cell disease (SCD). SCD is a genetic disorder of the hemoglobin, with blood vessel and multi-organ involvement. The distribution of olinciguat to the vasculature as well as to organs with high blood flow, such as the kidney and lungs, was expected to make it particularly well suited for the potential treatment of SCD. By amplifying nitric oxide signaling, the company expected olinciguat to have the potential to improve local blood flow to organs, reduce vascular inflammation and reduce the proportion of sickled cells.