Benzinga | Dec 9, 2020 07:31AM EST

Cytokinetics Announces Progression Of REDWOOD-HCM To Cohort 2

SOUTH SAN FRANCISCO, Calif., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (NASDAQ:CYTK) today announced the progression of REDWOOD-HCM following the conduct of an interim analysis of data from Cohort 1. REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM) is an ongoing Phase 2 clinical trial of CK-3773274 (CK-274), a next-generation cardiac myosin inhibitor in development for the potential treatment of hypertrophic cardiomyopathy (HCM).



The interim analysis of data from Cohort 1 of REDWOOD-HCM showed patients experienced substantial reductions in the average resting left ventricular outflow tract gradient (LVOT-G) as well as the post-Valsalva LVOT-G (defined as resting gradient <30 mmHg and post-Valsalva gradient <50 mmHg). These clinically relevant decreases in pressure gradients were achieved with only modest decreases in average left ventricular ejection fraction (LVEF); there were no dose interruptions due to LVEF falling below 50%, the prespecified safety threshold. Pharmacokinetic data were similar to those observed in Phase 1. In addition, the safety and tolerability data were supportive of continued dose escalation with no serious adverse events attributed to study treatment reported by the investigators.

Based on these results from Cohort 1, the Steering Committee and the Data Monitoring Committee of REDWOOD-HCM have recommended that the trial proceed to Cohort 2. The second cohort is open for enrollment in centers in North America and Europe. Enrollment in Cohort 2 of REDWOOD-HCM is expected to complete in Q1 2021 and full results from REDWOOD-HCM across both Cohort 1 and Cohort 2 are expected in mid-2021.

"We are encouraged that clinically relevant reductions in the LVOT gradient were achieved within four to six weeks in the majority of patients of Cohort 1 in this interim analysis," said Fady I. Malik, M.D., Ph.D., Cytokinetics' Executive Vice President of Research & Development. "Given the observed safety profile and opportunity to achieve further reductions of the LVOT-G in some patients, we are pleased to dose escalate in Cohort 2. We hope to rapidly enroll Cohort 2 with the goal of sharing results from REDWOOD-HCM in the middle of 2021 as may support progression of CK-274 to a planned Phase 3 by the end of next year."