Business
Cytokinetics Announces Progression of REDWOOD-HCM to Cohort 2
Interim Analysis of Data from Cohort 1 Demonstrate Substantial Effects of CK-274 to Reduce LVOT Gradient in Patients with Obstructive Hypertrophic
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Interim Analysis of Data from Cohort 1 Demonstrate Substantial Effects of CK-274 to Reduce LVOT Gradient in Patients with Obstructive Hypertrophic Cardiomyopathy with No Dose Interruptions Due to Left Ventricular Ejection Fraction Below 50%\nSOUTH 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 or post-Valsalva LVOT-G >50 mmHg), the patient was up-titrated to receive 10 mg (or placebo) for two weeks; similarly, if escalation criteria were met at four weeks, the patient up-titrated again to receive 15 mg (or placebo) and continued study drug until 10 weeks. If escalation criteria were not met at Week 2 or 4, the patient continued at the same dose for the rest of the trial. At the cut-off date for this interim analysis, echocardiographic core lab data were available from 11 patients through Week 6 for review while all 21 patients contributed safety data. Following a review of the aggregate, unblinded dataset, the Data Monitoring Committee of REDWOOD-HCM endorsed the recommendation jointly made by Cytokinetics and the Steering Committee of REDWOOD-HCM to proceed to Cohort 2 with doses of 10 mg, 20 mg, and 30 mg, once-daily. Screening of patients for Cohort 2 of REDWOOD-HCM has commenced. REDWOOD-HCM: Clinical Trial Design REDWOOD-HCM is a multi-center, randomized, placebo-controlled, double-blind, dose finding clinical trial of CK-274 in patients with symptomatic obstructive HCM (oHCM). The primary objective of the trial is to determine the safety and tolerability of CK-274. The secondary objectives are to describe the concentration-response relationship of CK-274 on the resting and post-Valsalva left ventricular outflow tract gradient as measu...