(ANSA) - ROME - A new drug capable of inhibiting a protein produced by the heart reduces the need for interventricular septal reduction procedures in patients with severe symptomatic hypertrophic obstructive cardiomyopathy.
After 16 weeks of treatment, it led to an improvement in key cardiac parameters.
These are the data from a phase 3 clinical trial that was presented by Bristol Myers Squibb at the 71st Annual Scientific Session of the American College of Cardiology.
Hypertrophic obstructive cardiomyopathy is a chronic progressive disease in which excessive contraction of the heart muscle and reduced filling capacity of the left ventricle can make it difficult for blood to circulate to the rest of the body, leading to the development of debilitating symptoms and cardiac dysfunction.
Study participants were on treatment regimens at maximum tolerated levels when they entered the study and remained so for the duration of the study.
Mavacamten, a first-in-class myosin inhibitor, which means that it has different mechanisms of action from those on the market, was assigned to a group of 56 patients and the same number received placebo.
At 16 weeks from the start of the study, of the patients treated with mavacamten, 82% no longer needed surgery, compared with 23% of the patients who received placebo.
Patients in the mavacamten group also demonstrated a reduction in left ventricular outflow tract gradients, improved quality-of-life measures, and improved cardiac biomarkers.
No new safety signs were observed.
"The data presented today are clinically significant and have demonstrated the potential to influence the parameters that make patients eligible for septal reduction procedures," explains Milind Desai, director of the HCM center and director of clinical operations, Heart, Vascular & Thoracic. Institute, Cleveland Clinic.