Bristol Myers Squibb’s mavacamten delivers positive topline results from Phase III VALOR-HCM in adults with symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM) who are eligible for septal reduction therapy (SRT) and have been referred for an invasive procedure.
Mavacamten is a first-in-class, oral, allosteric modulator of cardiac myosin being studied as treatment for obstructive HCM.
VALOR-HCM is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study with over 100 patients enrolled on a 1:1 basis to receive mavacamten or placebo.
According to Bristol Myers Squibb, in clinical and preclinical studies, mavacamten has consistently reduced biomarkers of cardiac wall stress, lessened excessive cardiac contractility, increased diastolic compliance and lessened left ventricular outflow tract (LVOT) gradients. Mavacamten is an investigational therapy and is not approved for use in any country.
VALOR-HCM met its primary goal at week 16. The safety profile of mavacamten was consistent with previous studies.
HCM is the most common form of genetic heart disease. HCM is chronic and progresses over time as the heart walls thicken and makes it harder for the heart of expand normally and fill with blood.
According to the American Heart Association, about 1 in every 500 people have HCM, but a large percentage of patients are undiagnosed.
In April, Bristol Myers Squibb will share the results of VALOR-HCM at the American College of Cardiology 71st Annual Scientific Session & Expo.