Rigel: Covid therapy approached, did not meet statistical significance in Ph. 3 primary efficacy endpoint

 Rigel Pharmaceuticals, Inc.  (Nasdaq: RIGL), today announced top-line efficacy and safety results from the FOCUS Phase 3 clinical 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 (p=0.0603) in the primary efficacy endpoint of the number of days on oxygen through Day 29. All prespecified secondary endpoints in the study numerically favored fostamatinib over placebo, including mortality, time to sustained recovery, change in ordinal scale assessment, and number of days in the ICU.

This multi-center, double-blind, placebo-controlled Phase 3 study, supported by the U.S. Department of Defense, enrolled 280 patients that were randomly assigned to either fostamatinib plus standard of care (SOC) (N=141) or matched placebo plus SOC (N=139). Treatment was administered orally twice daily for 14 days with a follow-up period to Day 60. The primary endpoint of this study was the number of days patients spent on supplemental oxygen through Day 29. Secondary endpoints were designed to assess mortality risk, patient improvement from severe disease, duration of hospitalization, and number of days in the ICU, as well as safety. There were no meaningful imbalances between treatment groups at baseline.

https://www.biospace.com/article/releases/rigel-announces-top-line-results-from-focus-phase-3-clinical-trial-of-fostamatinib-in-high-risk-hospitalized-covid-19-patients/