Biotechnology company Regeneron has announced it will not continue development of its antibody drug, suptavumab, after a failure in a Phase III clinical trial. The antibody was designed to prevent infant patients from contracting serious respiratory syncytial virus (RSV) infections, and failed to meet this primary endpoint in the late-stage study.
“We are disappointed in these results, as we had hoped suptavumab might offer a new option for the thousands of infants impacted by serious RSV infections every year,” said Dr. George D. Yancopoulos, President and Chief Scientific Officer of Regeneron. “Regeneron has a robust pipeline across many serious diseases, and we look forward to important data readouts from other programs in the coming weeks and months.”
A preventive antibody against RSV, MedImmune’s Synagis (palivizumab), has already been approved by the FDA. However this drug is not recommended for all patients, prompting Renegeron to try to develop an antibody that would meet this need.
While RSV is a fairly common respiratory virus, the symptoms of which are mild and flu-like, pediatric patients with undeveloped immune systems can be at risk of contracting a more serious infection. Each year in the US, RSV infection is associated with over 57,000 hospitalizations of children aged five years and younger, according to the Centers for Disease Control and Prevention (CDC).
Regeneron’s Phase III NURSERY clinical trial enrolled 1,149 healthy infants born preterm. Patients were randomly assigned to receive one dose of suptavumab, two doses of the antibody, or a placebo. The study specifically assessed the antibody’s ability to prevent medically-attended RSV infection, which was defined as an illness requiring hospitalization or outpatient care.
The company announced that they will present complete results from this clinical program at an upcoming scientific conference.