WILIMINGTON – Global biopharmaceutical company Incyte announced April 2 that it was studying whether it could repurpose its blockbuster drug Jakafi to aid in the treatment of COVID-19 patients.
The company headquartered in Alapocas reported that it was launching phase 3 clinical trials, with the assistance of the U.S. Food & Drug Administration, to study the effectiveness of its drug, known generically as ruxolitinib. The study will look at the responses of patients who receive ruxolitinib along with their standard treatment and those who don’t.
Given the growing number of COVID-19 deaths around the country, however, Incyte is also initiating a separate emergency Expanded Access Program (EAP) in the U.S., allowing eligible patients with severe symptoms to receive the drug while it is still being investigated.
Ruxolitinib is approved by the FDA for the treatment of myelofibrosis and polycythemia vera, part of a group of rare blood cancers known as myeloprolifertative neoplasms, as well as for steroid-refractory acute graft-versus-host disease. The drug became a winner for Incyte, and Jakafi now produces annual sales of more than a billion dollars.
As a Janus kinase inhibitor, ruxolitinib blocks the signaling of cytokine in the JAK-STAT pathway and may be effective in preventing potentially life-threatening cytokine storms and consequent organ failure. Cytokine storm is a severe overreaction of the immune system that can be caused by a viral infection, autoimmune condition, or other disease.
Because many COVID-19 patients with severe respiratory disease, such as pneumonia, have symptoms 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, Incyte reported.
Although the company has heard of several ongoing independent studies and anecdotal results regarding the effectiveness of ruxolitinib, the use of the drug in COVID-19 treatment is not currently approved by the FDA.
“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 Dr. Steven Stein, chief medical officer for Incyte, in a statement announcing the trial. “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 company added that there is “ample” supply of ruxolitinib for patients who need it for its approved uses as well as the clinical trial. Incyte is increasing manufacturing of the drug for “anticipated supply needs related to COVID-19 studies” and is working with its distributor to monitor the supply.
The clinical trial is being sponsored by Incyte and Novartis, which hold the American and international rights to Jakafi, respectively. The company declined to estimate a cost for the trial, saying only that it would be shared by Incyte and Novartis.
“The potential that Jakavi 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,” said John Tsai, head of global drug development and chief medical officer at Switzerland-based Novartis, in a statement.
While an Incyte spokesperson said the company could not estimate how long the clinical trial would take, she said “enrollment may be quick, and we intend to share the results as soon as possible after the study is complete.”
News of the clinical trial led to a big bump in Incyte’s stock value, rising more than 10% from its announcement to the market’s close Monday.
By Jacob Owens
