Business
Cyclerion Therapeutics Announces Topline Phase 2 Results for sGC Stimulator Praliciguat in Heart Failure with Preserved Ejection Fraction (HFpEF)
– Study in HFpEF patients did not meet primary endpoint; company discontinuing development of praliciguat in HFpEF – – Conference call to be held at 8:30 a.m.
About this update from Cyclerion Therapeutics, Inc.
[{"type":"text","content":"– Study in HFpEF patients did not meet primary endpoint; company discontinuing development of praliciguat in HFpEF – \n – Conference call to be held at 8:30 a.m. ET today – CAMBRIDGE, Mass., Oct. 30, 2019 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company developing soluble guanylate cyclase (sGC) stimulators for the treatment of serious and orphan diseases, today announced topline results from its CAPACITY Phase 2 proof-of-concept study of praliciguat, a once-daily, orally available systemic sGC stimulator, in heart failure with preserved ejection fraction (HFpEF). The study did not meet statistical significance on its primary endpoint of improved exercise capacity from baseline as compared to placebo, measured by cardiopulmonary exercise testing (CPET). There was clear evidence of drug exposure and pharmacological activity as judged by expected reductions in blood pressure. Praliciguat was generally well tolerated, and the safety profile supported investigation of praliciguat in other indications. While there were no trends observed in improving HFpEF symptoms, a positive trend in reducing HbA1c levels was observed in the subset of patients with diabetes. This is consistent with the results observed in the company’s Phase 2 study of praliciguat in diabetic nephropathy, which were also reported today. Cyclerion is discontinuing development of praliciguat in HFpEF. Full results from the study will be presented at a future medical meeting. “CAPACITY-HFpEF had an innovative design, focused on those patients we believed were more likely to respond to therapy. While we are disappointed with the study results, particularly given the unmet need in HFpEF, we are very grateful to the patients who participated, as well as the physicians, other study staff and our internal teams who ran a high-quality trial that enabled us to arrive at a clear result for this indication,” said Chris Wright, M.D., Ph.D., chief medical officer at Cyclerion. With its praliciguat Phase 2 studies completed, Cyclerion intends to focus its investments on near-term value-creation opportunities – including out-licensing praliciguat for diabetic nephropathy, advancing its STRONG SCD Phase 2 study of olinciguat in sickle cell disease, its Phase 1 study of IW-6463 for central nervous system disorders, as well a...