Incyte to launch ruxolitinib coronavirus clinical trial in US
Ruxolitinib coronavirus clinical trial : Incyte revealed that it is working with the US Food and Drug Administration (FDA) to launch the phase 3 RUXCOVID clinical trial to assess the efficacy and safety of ruxolitinib (Jakafi) plus standard-of-care (SoC) in patients with COVID-19 associated cytokine storm syndrome.
The ruxolitinib plus standard-of-care will be compared to standard-of-care therapy alone in the late-stage COVID-19 clinical trial, which will be funded by Incyte in the US and by Swiss pharma giant Novartis in other countries.
Incyte said that owing to the urgent nature of the novel coronavirus outbreak, it plans to begin a separate open-label emergency expanded access program (EAP) in the US, which would enable qualified patients suffering from severe COVID-19 associated cytokine storm to be treated with ruxolitinib while it is being studied for the indication.
Commenting on the ruxolitinib coronavirus clinical trial, Steven Stein – Chief Medical Officer at Incyte said: “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.
“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.”
Incyte to initiate ruxolitinib coronavirus clinical trial in US. Photo courtesy of Gerd Altmann from Pixabay
Discovered by Incyte scientists, ruxolitinib is a Janus kinase (JAK1/JAK2) inhibitor. Overactive signaling via the JAK-STAT pathway has been related to several types of cancer. These include a group of rare blood cancers called myeloproliferative neoplasms (MPNs), and also other serious immune-mediated conditions like graft-versus-host disease (GVHD).
As several patients with severe respiratory diseases such as pneumonia arising from COVID-19 have features consistent with cytokine storm and increased activation of the JAK-STAT pathway, it is hypothesized that ruxolitinib could play a role in treating such patients, said Incyte.
The US biopharma company claimed that independent investigators have shown interest in evaluating the potential of ruxolitinib to mitigate some of the effects of severe coronavirus infection. However, presently, there is limited evidence on the safety or efficacy of ruxolitinib in the clinical treatment of coronavirus and also the drug is currently not approved by the FDA for this indication.
Incyte said that there is enough commercial and clinical supply of ruxolitinib in the US to meet the requirements of patients receiving ruxolitinib in its approved indications, and those taking part in global clinical trials. The US biopharma company said that it is ramping up manufacturing efforts to respond to anticipated supply needs associated with COVID-19 clinical trials and is closely working with distribution partners to track the supply of ruxolitinib.