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

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.