Incyte announced the Company is working with the U.S. FDA to initiate a Phase 3 clinical trial (RUXCOVID) to evaluate the efficacy and safety of ruxolitinib (Jakafi®) plus standard-of-care (SoC), compared to SoC therapy alone, in patients with COVID-19 associated cytokine storm. The collaborative study will be sponsored by Incyte in the United States and Novartis outside of the United States.
Additionally, given the urgent nature of the COVID-19 pandemic, Incyte intends to initiate a separate open-label emergency Expanded Access Program (EAP) in the United States. The protocol will allow eligible patients with severe COVID-19 associated cytokine storm to receive ruxolitinib while it is being investigated for this indication.
“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,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “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.”
Ruxolitinib is a Janus kinase (JAK1/JAK2) inhibitor discovered by Incyte scientists. Overactive signaling through the JAK-STAT pathway has been associated with many types of cancer, including a group of rare blood cancers called myeloproliferative neoplasms (MPNs), as well as other serious immune-mediated conditions such as graft-versus-host disease (GVHD). Because many patients with severe respiratory disease (e.g., pneumonia) due to COVID-19 have features consistent with cytokine storm and increased activation of the JAK-STAT pathway, it is hypothesized that ruxolitinib may be able to play a role in treating these patients.
Independent investigators have expressed interest in studying the potential of ruxolitinib to mitigate some of the effects of severe COVID-19 infection, and we are aware of several ongoing independent studies and anecdotal results. However, currently, there is limited evidence on the safety or efficacy of ruxolitinib in the clinical treatment of COVID-19 and ruxolitinib is not currently FDA-approved for this use.
At present, there is ample commercial and clinical supply of ruxolitinib in the United States to meet the needs of U.S. patients receiving ruxolitinib in its approved indications, and those participating in global clinical trials. Incyte is increasing manufacturing efforts to respond to anticipated supply needs related to COVID-19 studies and is working closely with distribution partners to monitor the supply of ruxolitinib.
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.