Bayer starts phase II/III study with vericiguat in children with heart failure

Bayer and its development partner MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA) announced that the first patient has been enrolled in the Phase II/III VALOR trial. VALOR will investigate the efficacy, afety, and pharmacokinetics of vericiguat (Verquvo) in pediatric patients aged greater than 28 days to 18 years with heart failure due to left ventricular systolic dysfunction. VALOR is the pivotal study in pediatric heart failure with vericiguat.

Heart failure can occur at any age and rates in children are increasing. Although the incidence of pediatric heart failure is low at up to 7 per 100,000 children, the impact on the children and adolescents affected is high, with an in-hospital mortality rate of 7–26%. Heart failure symptoms include failure to thrive, shortness of breath or increased respiratory frequency (tachypnea), tiredness and fatigue, fluid retention and reduced ability to do physical tasks. Children with heart failure are 24 times more likely to be hospitalized than children without heart failure.

“Although heart failure is more common in older adults it is important to be aware that children can be affected too and there are few clinical trials that have been conducted specifically in a pediatric heart failure population,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Research and Development. “With the start of our pediatric study VALOR we want to address this gap and will investigate if vericiguat can be used as a treatment option for pediatric heart failure.”

VALOR is a randomized, placebo-controlled, double-blind trial which enrolls patients in greater than 28 days through less than 18 years of age with a history of symptomatic chronic heart failure resulting from systemic left ventricular systolic dysfunction and a reduced left ventricular ejection fraction. The primary endpoint is change in plasma concentration of N-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16. More information can be found online at www.clinicaltrials.gov (NCT05714085).