Novartis and Incyte are planning to initiate a new clinical trial to evaluate ruxolitinib (Jakafi) in certain patients with COVID-19, according to a press release.
The phase 3 clinical trial will investigate the use of ruxolitinib for the treatment of a type of severe immune overreaction called cytokine storm that can result from coronavirus infection and can lead to life-threatening respiratory complications. The collaborative study will be sponsored by Incyte in the United States and Novartis outside of the United States.
There is currently limited evidence on the safety or efficacy of ruxolitinib in the treatment of COVID-19; however, investigators have noted the potential of ruxolitinib in the treatment of severe COVID-19 based on independent studies and anecdotal results.
Ruxolitinib is an oral janus kinase (JAK) inhibitor currently approved for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis.
The trial will assess ruxolitinib in combination with standard-of-care therapy, compared with standard-of-care therapy alone, in patients with severe COVID-10 pneumonia as a result of SARS-CoV-2 infections.
Incyte also intends to initiate a separate open-label emergency Expanded Access Program (EAP) in the United States, which will allow eligible patients with COVID-19 to receive the drug while it is being investigated. Additionally, Novartis has set up an international compassionate use program for eligible patients, and is taking steps to manage the anticipated increase in ruxolitinib requests without interrupting access for patients taking the drug for its licensed indications.
“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 of 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.”
The phase 3 study and EAP protocols are currently awaiting potential approval by the FDA, Incyte said.
1. Incyte Announces Plan to Initiate a Phase 3 Clinical Trial of Ruxolitinib (Jakafi) as a Treatment for Patients with COVID-19 Associated Cytokine Storm [news release]. Incyte’s website. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-plans-initiate-phase-3-clinical-trial. Accessed April 6, 2020.