WASHINGTON (dpa-AFX) - Rigel Pharmaceuticals Inc. (RIGL) said that data from NIH/NHLBI-Sponsored phase 2 trial of fostamatinib in hospitalized COVID-19 patients were published in clinical infectious diseases, an official publication of the Infectious Disease Society of America.
The company noted that the results from the 59 patient Phase 2 trial demonstrated that the addition of fostamatinib to standard of care, 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. Patients treated with fostamatinib had less severe adverse events.
The company noted that the study was not powered to test clinical efficacy, but 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. The study date suggested that fostamatinib may provide an additional therapeutic benefit compared to current standard of care alone.
'Additional studies are needed to confirm the efficacy findings and show how fostamatinib may address the dysregulated immune response observed in COVID-19 patients,' said Jeffrey Strich, principal investigator of the study and a physician at the NIH Clinical Center.
The study met the primary endpoint showing fostamatinib did not increase the incidence of serious adverse events compared with placebo.
The overall incidence of serious adverse events by Day 29 was approximately 50% less in the fostamatinib group compared with the placebo group. The most frequent serious adverse event reported by Day 29 was hypoxia, occurring in 1 patient receiving fostamatinib and 3 patients receiving placebo.
At Day 29, in the overall population there were zero deaths in the fostamatinib group compared to 3 in the placebo group.
There were 4 intubated patients in the trial on mechanical ventilation upon enrollment with 2 patients randomized to each treatment group. Both patients in the fostamatinib group were extubated and discharged from the hospital, while both patients in the placebo group deceased.
The company noted that its phase 3 clinical trial in COVID-19, which it expects to complete later this year, will provide the company with further understanding of the safety and efficacy of fostamatinib and its potential as a new therapy for these patients.
In Mid-August, Rigel Pharmaceuticals said that the U.S. Food and Drug Administration did not issue emergency use authorization for fostamatinib for the treatment of COVID-19 in hospitalized adults, due to insufficient clinical data.
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