Rigel Pharmaceuticals, Inc. Announces Data from NIH/NHLBI-Sponsored Phase 2 Trial of Fostamatinib in Hospitalized COVID-19 Patients Published in Clinical Infectious Diseases
September 01, 2021 at 07:30 am EDT
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Rigel Pharmaceuticals, Inc. announced the publication of results from a Phase 2 clinical trial evaluating the safety of fostamatinib for the treatment of hospitalized patients with COVID-19, in Clinical Infectious Diseases, an official publication of the Infectious Disease Society of America. The study was sponsored by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), in collaboration with Inova Health System. The results from the 59 patient Phase 2 trial demonstrated that the addition of fostamatinib to standard of care (SOC), which included the antiviral remdesivir and the steroid dexamethasone, was well tolerated and associated with clinically meaningful improvement in clinical outcomes in hospitalized COVID-19 patients who required supplemental oxygen. While the study was not powered to test clinical efficacy, numerous prespecified secondary endpoints consistently favored fostamatinib, including mortality, time to sustained recovery, change in ordinal scale assessment, number of days on oxygen, and number of days in the ICU, suggesting that fostamatinib may provide an additional therapeutic benefit compared to current SOC alone.
Rigel Pharmaceuticals, Inc. is a biotechnology company. The Company is engaged in developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. It is focused on products that address signaling pathways that are critical to disease mechanisms. Its first product is TAVALISSE (fostamatinib disodium hexahydrate) tablets, the approved oral spleen tyrosine kinase inhibitor for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Its second product is REZLIDHIA (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. Its GAVRETO (pralsetinib) product is a once daily, small molecule, oral, kinase inhibitor of wild type rearranged during transfection (RET) and oncogenic RET fusions.
Rigel Pharmaceuticals, Inc. Announces Data from NIH/NHLBI-Sponsored Phase 2 Trial of Fostamatinib in Hospitalized COVID-19 Patients Published in Clinical Infectious Diseases