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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

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