Kristin Brooks02.01.21
Rigel Pharmaceuticals, Inc. has been awarded $16.5 million by the U.S. Department of Defense's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to support Rigel's ongoing Phase 3 clinical trial to evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients.
The trial will evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients without respiratory failure that have certain high-risk prognostic factors. This multi-center, double-blind, placebo-controlled, adaptive design study is expected to enroll over 300 patients that will be randomized to either fostamatinib plus standard of care (SOC) or matched placebo plus SOC. Treatment will be administered orally twice daily for 14 days. The primary endpoint is the proportion of subjects who progress to severe/critical disease within 29 days.
Fostamatinib is marketed in the U.S. as TAVALISSE tablets, and is approved in the U.S., Europe, and Canada as a treatment for adult chronic immune thrombocytopenia (ITP).
"We are grateful to receive this funding from the DOD and for their demonstrated commitment towards finding safe and effective treatments for COVID-19 patients," said Raul Rodriguez, Rigel's president and CEO. "These additional resources will contribute significantly to the advancement of our Phase 3 trial. Data from this trial, coupled with findings from the NIH-sponsored Phase 2 trial, which is anticipated to report topline results in April 2021, could potentially facilitate an EUA filing for a much needed therapy for hospitalized COVID-19 patients in the U.S."
The trial will evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients without respiratory failure that have certain high-risk prognostic factors. This multi-center, double-blind, placebo-controlled, adaptive design study is expected to enroll over 300 patients that will be randomized to either fostamatinib plus standard of care (SOC) or matched placebo plus SOC. Treatment will be administered orally twice daily for 14 days. The primary endpoint is the proportion of subjects who progress to severe/critical disease within 29 days.
Fostamatinib is marketed in the U.S. as TAVALISSE tablets, and is approved in the U.S., Europe, and Canada as a treatment for adult chronic immune thrombocytopenia (ITP).
"We are grateful to receive this funding from the DOD and for their demonstrated commitment towards finding safe and effective treatments for COVID-19 patients," said Raul Rodriguez, Rigel's president and CEO. "These additional resources will contribute significantly to the advancement of our Phase 3 trial. Data from this trial, coupled with findings from the NIH-sponsored Phase 2 trial, which is anticipated to report topline results in April 2021, could potentially facilitate an EUA filing for a much needed therapy for hospitalized COVID-19 patients in the U.S."
