Incyte and Novartis announced that the companies plan to initiate a phase 3 collaborative study to assess ruxolitinib plus standard-of-care, versus standard care alone, in patients suffering from COVID-19-associated cytokine storm. The clinical trial will be sponsored by Incyte in the US, where the company markets the JAK1/JAK2 inhibitor as Jakafi, and Novartis outside of the country, where the Swiss drugmaker sells the medicine under the name Jakavi.
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.”
Incyte also said it intends to launch a separate expanded access programme (EAP) in the US to allow eligible patients with COVID-19-associated cytokine storm to receive the therapy. The company added that it has an “ample commercial and clinical supply” of the drug in the US and is boosting manufacturing efforts in response to the pandemic. “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,” Mr. Stein noted.
John Tsai, head of global drug development at Novartis, remarked that “the potential that [ruxolitinib] could lead to faster recovery times for COVID-19 patients with fewer requiring intensive care and mechanical ventilation is encouraging and absolutely merits further investigation.” He said the company is now working to finalize the study plan and to enroll eligible patients, “as well as put in place a process to provide access for patients unable to participate in the trial.”
Novartis says it has also set up an international compassionate-use programme for eligible patients, and is “taking steps to manage the anticipated increase in COVID-19-related requests” for the drug, without interrupting access for patients taking it for its already licensed indications.
The JAK1/JAK2 inhibitor is currently approved in multiple countries for certain patients with polycythemia vera and myelofibrosis, while in the US, it is also indicated to treat steroid-refractory acute graft-versus-host disease. Novartis licensed rights to the drug, formerly known as INCB18424, from Incyte in 2009 for all haematology-oncology indications outside the US.