Incyte drug could be part of COVID-19 treatment
A global biopharmaceutical company based in Delaware is working to get one of its drugs approved to treat the new coronavirus disease.
Officials at Incyte in Wilmington think the company’s widely-used drug Jakafi—or more generally ruxolitinib—could be used to save the lives of people critically ill with COVID-19.
Some COVID patients get what is called a cytokine storm in the later stages of the illness which can lead to pneumonia and require a ventilator. This is the body’s own defense systems going overboard and attacking the lungs.
Incyte Chief Medical Officer Steven Stein says ruxolitinib can inhibit this process, but he warns if it is overdone the drug could also stop the body from fighting the virus.
“So the idea is to try and—appropriately with the right dose of the compound—sort of weed the therapeutic ratio so that you can keep the body with an adequate antiviral response, but at the same time stop the cytokine storm so somebody doesn’t get into trouble,” said Stein.
Ruxolitinib is approved by the Food and Drug Administration (FDA) for the treatment of blood cancers myelofibrosis and polycythemia vera and other diseases.
Incyte is working with the FDA to approve ruxolitinib in the coming days for clinical trials to determine the drug’s efficacy in treating COVID-19, and trying to get an Expanded Access Program approved to make the drug more widely available in the meantime.
“What that does, is make the drug available within a protocol, but a pretty simple protocol, where everybody would get the compound if they meet the criteria,” said Stein. “So if they have COVID-19 infection, are in respiratory trouble, have evidence of cytokine storm.”
Incyte is looking to then conduct a randomized protocol in concert with Novartis, the company that owns the international rights to Jakafi.
“Probably be roughly 350 patients. The patients will be randomized either to ruxolitinib or to a placebo control, and we’ll get a readout very quickly, given the situation, whether the drug works or not,” Stein said.
Stein says even with the regulatory and testing process “massively accelerated” during the pandemic, full approval could still take a couple months.