Rigel Pharma (RIGL) Reports Complete Patient Enrollment for NIH/NHLBI-Sponsored Phase 2 Trial of Fostamatinib in Hospitalized COVID-19 Patients
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Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) today announced the completion of patient enrollment in a multi-center Phase 2 clinical trial to evaluate the safety of fostamatinib, Rigel's oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of hospitalized COVID-19 patients. The study is sponsored by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), in collaboration with Inova Health System. Fostamatinib is marketed in the U.S. as TAVALISSE® (fostamatinib disodium hexahydrate) tablets, and is approved in the U.S., Europe, and Canada as a treatment for adult chronic immune thrombocytopenia (ITP).
The Phase 2 clinical trial is being conducted at the NIH Clinical Center in Bethesda, Maryland, the nation's largest hospital devoted entirely to clinical research, and Inova Fairfax Hospital.
This is a double-blind, placebo-controlled Phase 2 clinical trial that randomly assigned fostamatinib plus standard of care (SOC) or matched placebo plus SOC (1:1) to 58 evaluable patients who are a 5 to 7 on the 8-point ordinal scale (requiring supplemental oxygen via nasal canula or non-invasive ventilation, requiring mechanical ventilation or extracorporeal membrane oxygenation). Treatment will be administered orally twice daily for 14 days. There will be a follow-up period to day 60. The primary endpoint of this study is cumulative incidence of serious adverse events (SAE) through day 29, with multiple secondary endpoints designed to assess the early efficacy and clinically relevant endpoints of disease course as well as in vitro biological correlatives evaluating the effects of the drug on pathways involved in the pathophysiology of COVID-19, including NETosis. The NHLBI and Rigel expect to report topline data from this clinical trial in April 2021.
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