View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
July 20, 2021updated 25 Nov 2021 9:59am

Cytokinetics’ heart disease drug yields positive data in Phase II study

Data from the Phase II trial support the entry of the drug candidate into a planned Phase III registrational trial.

A Phase II clinical trial of Cytokinetics’ investigational drug candidate, CK-3773274 (CK-274), has shown positive top-line data from first and second cohorts in hypertrophic cardiomyopathy (HCM) patients.

Data from the REDWOOD-HCM trial revealed statistically significant decreases in the average resting left ventricular outflow tract pressure gradient (LVOT-G) and the average post-Valsalva LVOT-G from baseline when treated with CK-274 for ten weeks.

Compared to placebo, most of the CK-274-treated participants reached the target treatment goal, determined as resting gradient and post-Valsalva gradient of less than 30mmHg and 50mmHg, respectively, at week ten.

LVOT-G reductions were observed in two weeks of starting the CK-274 treatment. These effects were maximised in two to six weeks of the dose titration initiation and maintained until the end of the ten-week treatment period.

The LVOT-G reductions were also reported to be dose-dependent and patients experienced higher decreases with increasing CK-274 doses.

CK-274 was generally well-tolerated during the trial with the occurrence of adverse events being similar between treatment groups. The drug candidate was not associated with any serious adverse events.

Cytokinetics Research & Development executive vice-president Fady Malik said: “The combined data from Cohorts 1 and 2 in REDWOOD-HCM met our high expectations for this trial of CK-274 in patients with obstructive HCM, given the observed onset of response to initiation of treatment, magnitude and breadth of response, reversibility of LVEF decreases and favourable tolerability profile.”

CK-274 is an oral, small-molecule inhibitor of cardiac myosin intended to mitigate hypercontractility related to HCM.

A multi-centre, randomised, placebo-controlled, double-blind, dose-finding Phase II trial, REDWOOD-HCM assessed the drug in symptomatic obstructive HCM patients receiving background treatment.

Safety and tolerability of CK-274 were the primary objectives while secondary objectives were the concentration-response link between CK-274 and the resting and post-Valsalva LVOT-G, established using echocardiography over the treatment period.

The REDWOOD-HCM data inform dose selection and back the entry of CK-274 into a planned Phase III registrational trial set to commence before year-end.

In October 2020, Cytokinetics and its partners Amgen and Servier announced mixed results from the Phase III GALACTIC-HF trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction.

Related Companies

Free Whitepaper
img

Unlocking the clinical trial potential of Africa

Ongoing improvements around infrastructure, continued investment, and being home to one of the world’s largest working age populations, means that Africa’s role in the clinical trials market has transformed. In this whitepaper, Oximio outlines the dynamics of today’s clinical trial market in Africa, including the key challenges the region is facing and how sponsors can overcome them to unlock the continent’s growing potential.
by Oximio
Enter your details here to receive your free Whitepaper.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU