This article is more than 5 years old. Information may no longer be current.

Regeneron discontinues development of antibody for RSV

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Regeneron Pharmaceuticals, Inc. announced today that a recent phase 3 trial assessing the safety and efficacy of suptavumab — the company’s investigational antibody to respiratory syncytial virus, or RSV — failed to meet its primary endpoint of preventing medically attended RSV in infants.

Although suptavumab did appear to be effective in a subgroup of patients, Regeneron plans to discontinue further clinical development of the antibody, according to a press release.

“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,” George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, said in the release. “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.”

The phase 3 NURSERY Pre-term study included 1,149 healthy preterm infants aged 6 months or younger at the start of the study. The participants were randomly assigned 1:1:1 to receive either 30 mg/kg of suptavumab administered as a single dose, 30 mg/kg of suptavumab administered as two doses 8 weeks apart, or placebo. They were followed for 150 days and were considered “medically attended” if they were hospitalized or sought medical care for RSV infection. Additional study data will be presented at a future medical conference, the release said.

According to WHO, there are more than 20 candidates in the RSV vaccine pipeline sponsored by 12 different companies or government organizations. The only other candidate in phase 3 development, an RSV F-protein recombinant nanoparticle vaccine (Novavax), also failed to meet both primary and secondary endpoints of preventing moderate-to-severe RSV-associated lower respiratory tract disease and reducing the incidence of all symptomatic respiratory disease due to RSV in 11,856 adults aged 60 years and older.

Disclosure: Yancopoulos is an employee of Regeneron.