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Mixed Phase 3 Outcomes Cloud Future of Regeneron and Sanofi’s COPD Candidate Itepekimab

Regeneron plans to consult regulators on next steps for its experimental COPD therapy developed with Sanofi

The Regeneron Pharmaceuticals company logo is seen on a building at the company's Westchester campus in Tarrytown, New York, U.S. September 17, 2020. Picture taken September 17, 2020. REUTERS/Brendan McDermid/File Photo
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Overview

  • One of two Phase 3 trials of itepekimab showed a 27% reduction in moderate or severe COPD exacerbations versus placebo at 52 weeks
  • The companion study failed to meet its primary endpoint despite earlier indications of benefit
  • Regeneron’s share price fell nearly 13% in premarket trading, marking a four-year low
  • Itepekimab works by binding to and inhibiting interleukin-33 to reduce lung inflammation in former smokers with COPD, a population of about 16 million U.S. adults
  • Regeneron and Sanofi are reviewing the mixed data and will discuss the trial results with regulatory authorities before determining next steps