NIH Launches Trial of Rigel’s Fostamatinib for COVID-19 Patients

The National Institutes of Health (NIH) has launched a phase 2 clinical trial of Rigel Pharmaceuticals’ fostamatinib for the treatment of hospitalized COVID-19 patients.

Sold under the brand name Tavalisse, fostamatinib is currently approved in the U.S. and Europe as a second-line treatment for chronic immune thrombocytopenia, a condition that lowers blood-platelet counts. The drug works by inhibiting the activity of the spleen tyrosine kinase (SYK) enzyme.

The study will evaluate the drug’s safety and efficacy compared to a placebo in 60 COVID-19 patients who require supplemental oxygen or ventilation. Participants will be treated twice a day for 14 days.

“This agent was chosen to be studied because of its ability to selectively target specific immune pathways that we believe may contribute to the mortality of COVID-19, rather than taking a ‘shotgun’ approach with drugs that may totally incapacitate the immune system,” said Richard Childs, clinical director of NIH’s National Heart, Lung, and Blood Institute, which is leading the study.

Results from the trial should be available about a month after the last patient is enrolled, hopefully in December, Childs said.

Tavalisse is also being evaluated in a phase 2 trial led by Imperial College London to determine its efficacy in treating COVID-19 pneumonia. That trial got under way in mid-July. — James Miessler