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.
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.”
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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