Phase III Trial Planned for Ruxolitinib to Treat COVID-19

A phase III trial is being planned to explore the use of ruxolitinib (Jakafi) to treat patients with coronavirus disease 2019 (COVID-19)—related cytokine storm, according to a press release from Incyte regarding discussions with the FDA.¹

The global trial will be a collaboration with Incyte sponsoring the trial in the United States and Novartis sponsoring the trial outside of the United States. Incyte is also planning to open an emergency Expanded Access Program for patients in urgent need to receive the treatment.

“Our intent is to build on emerging evidence from independent studies to further establish the role ruxolitinib could play in balancing immune response to the infection and therefore potentially improving outcomes of patients with COVID-19 associated cytokine storm,” Steven Stein, MD, chief medical officer, Incyte, 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.”

In a letter inThe Lancet,Puja Mehta, MD, and colleagues wrote that a subgroup of patients with severe COVID-19 may have cytokine storm syndrome that resembles secondary hamophagocytic lymphohistiocytosis, a hyperinflammatory syndrome. Characteristics of this cytokine storm profile in patients with severe COVID-19 include: increased interleukin (IL)-2, IL-7, granulocyte-colony stimulating factor, interferon-γ inducible protein 10, monocyte chemoattractant protein 1, macrophage inflammatory protein 1-α, and tumor necrosis factor-α.²

The study authors also noted in the correspondence that JAK inhibition, as with ruxolitinib, could potentially affect both inflammation and cellular viral entry in cases of COVID-19.

Incyte has suggested that ruxolitinib, a JAK1/2 inhibitor, may be beneficial in treating patients with COVID-19—associated cytokine storm as many features of patients with severe respiratory disease from the virus have features that appear consistent with increased activation of the JAK-STAT pathway.

Ruxolitinib is currently approved by the FDA for the treatment of patients with myeloproliferative neoplasms, including patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea (Hydrea) and patients with intermediate or high-risk myelofibrosis, and for the treatment of adult and pediatric patients with steroid-refractory acute graft-versus-host disease.

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References

1. Incyte Announces Plans to Initiate a Phase 3 Clinical Trial of Ruxolitinib (Jakafi&reg;) as a Treatment for Patients with COVID-19 Associated Cytokine Storm [news release] Wilmington, DE: Incyte; April 2, 2020.https://bwnews.pr/2ypBaEA. Accessed April 3, 2020.
2. Mehta P, McAuley DF, Brown M, et al; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression.Lancet. 2020;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0.