TARRYTOWN, N.Y., Aug. 14, 2017 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that a Phase 3 study evaluating suptavumab (REGN2222), an antibody to respiratory syncytial virus (RSV), did not meet its primary endpoint of preventing medically-attended RSV infections in infants. Suptavumab did show signs of efficacy in a subgroup of patients. Adverse events were generally balanced between suptavumab and placebo. Regeneron plans to discontinue further clinical development of this antibody.
"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 George D. Yancopoulos, M.D., Ph.D., 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."
The double-blind, placebo-controlled global Phase 3 NURSERY Pre-term study enrolled 1,149 healthy pre-term infants. Patients were randomized in a 1:1:1 ratio to one of three study groups: suptavumab 30 mg/kg as a single dose; suptavumab 30 mg/kg administered as two doses 8 weeks apart; or placebo. Assessment of the primary endpoint occurred through Day 150 of treatment. Patients were considered 'medically-attended' if they required hospitalization and/or sought medical care for a centrally-adjudicated RSV infection. Pre-term infants in the study had a gestational age of less than 36 weeks and were 6 months old or younger at the beginning of the study.
Data from the study will be presented at a future medical congress.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for nearly 30 years by physician-scientists, our unique ability to consistently translate science into medicine has led to six FDA-approved treatments and over a dozen product candidates, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite® technologies, including VelocImmune® which yields optimized fully-human antibodies, and ambitious initiatives such as the Regeneron Genetics Center, one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
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that, if upheld on appeal, would prohibit Regeneron and Sanofi from marketing, selling, or commercially manufacturing Praluent in the United States, the outcome of any appeals regarding such injunction, the ultimate outcome of such litigation, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the fiscal year ended December 31, 2016 and its Form 10-Q for the quarterly period ended June 30, 2017. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is
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