Another Clinical Trial Setback For Rigel Pharma's Lead Program, This Time For COVID-19

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  • Rigel Pharmaceuticals Inc RIGL announced topline efficacy and safety results from the FOCUS Phase 3 trial of fostamatinib in hospitalized COVID-19 patients without respiratory failure who have certain high-risk prognostic factors. 
  • The trial approached but did not meet statistical significance in the primary efficacy endpoint of the number of days on oxygen through Day 29. 
  • All prespecified secondary endpoints numerically favored fostamatinib over placebo, including mortality, time to sustained recovery, change in ordinal scale assessment, and the number of days in the ICU.
  • Related: Rigel Pharmaceuticals' Fostamatinib Flunks In Late-Stage Rare Blood Disorder Trial.
  • The U.S. Department of Defense-backed trial enrolled 280 patients.
  • The mean number of days on oxygen in the fostamatinib arm was 6.9 days compared to 9.0 days in the placebo arm.
  • In the overall population, four deaths were in the fostamatinib group compared to 8 in the placebo group.
  • The mean change from baseline in clinical status score to Day 15 was -2.4 vs. -1.9 for placebo.
  • The median number of days to first sustained hospital discharge by Day 29 was six days for fostamatinib and seven days for placebo.
  • The proportion of patients alive and oxygen free on Day 29 was 85.1% vs. 73.4%.
  • Price Action: RIGL shares closed at $0.75 on Tuesday.
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