A paper published last month suggested that one of the reasons behind severe Covid-19 disease might be cytokine storm, a kind of out-of-control immune system reaction. In response, that has become the focus of several clinical trials testing drugs for Covid-19, including one that is planned to launch soon.
Wilmington, Delaware-based Incyte said Thursday that it is working with the Food and Drug Administration to start a Phase III trial, titled RUXCOVID, comparing Jakafi (ruxolitinib) plus standard-of-care treatment against standard of care alone as a treatment for cytokine storm associated with Covid-19. Incyte would sponsor the trial in the U.S., while Swiss drugmaker Novartis would sponsor it in other countries. A separate expanded-access program (EAP) is also planned to allow certain patients to obtain the drug while it is under investigation.
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Jakafi is currently approved to treat certain patients with myelofibrosis and polycythemia vera, which are both blood cancers, as well as acute graft-versus-host disease.
Cytokine storm and a related term, cytokine release syndrome, refers to an overly powerful immune response caused by the body’s immune system releasing large amounts of inflammatory cytokines. Cytokine storms have been theorized as a reason why the 1918 influenza pandemic primarily killed young people, and cytokine release syndrome is a common side effect of CAR-T cell therapies used to treat certain blood cancers.
More recently, according to an article last month in The Lancet, it has been suggested that cytokine storm may also be affecting a subgroup of patients with severe Covid-19.
“Our intent is to build on emerging evidence from independent studies to further establish the role [Jakafi] could play in balancing immune response to the infection and therefore potentially improving outcome sof patients with Covid-19-associated cytokine storm,” Incyte chief medical officer Steven Stein said in a statement. “We recognize the significant and urgent medical need of patients with severe Covid-19 infection, and we are working with the FDA in an effort to rapidly advance the RUXCOVID and EAP studies.”
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The FDA announced a program this week designed to more rapidly advance clinical trials in Covid-19 by redeploying some staff and streamlining review processes. As of Friday morning, RUXCOVID had not been posted to ClinicalTrials.gov, but a study at Toronto’s Princess Margaret Cancer Centre investigating Jakafi in Covid-19-related pneumonia had been posted on Thursday, though it was not yet recruiting patients.
Other drugs are also being tested as potential treatments for Covid-19 cytokine storm, in particular Roche’s Actemra (tocilizumab), an arthritis drug that is also approved and commonly used to treat cytokine release syndrome in patients receiving CAR-T cell therapies. The Lancet paper pointed to several therapeutic options for cytokine storm in Covid-19, including steroids, intravenous immunoglobulin, selective cytokine blockade – via drugs like Actemra – and JAK inhibitors, a class that includes Jakafi as well as Pfizer’s Xeljanz (tofacitinib).
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