Novartis plans to initiate a Phase III clinical trial in collaboration with Delaware-based Incyte to evaluate the use of Jakafi (Jakavi outside the United States) for the treatment of a type of severe immune overreaction associated with coronavirus.
Known as cytokine storm, the condition can lead to life-threatening respiratory complications in patients with COVID-19 (coronavirus).
The decision is based on preclinical evidence and preliminary reports from independent studies and is supported by extensive data on the safety and efficacy of Jakafi.
Jakafi, best known for treating blood disorders, has led to a rapid expansion of Incyte in Delaware. Sales of the drug now total $1.4 billion.
The proposed trial will assess Jakafi in combination with standard of care (SoC) therapy, compared to standard of care therapy alone, in patients with severe COVID-19 pneumonia.
The late-stage trial, while promising, is no guarantee that results will lead to a breakthrough. Still, Incyte’s stock price did show a 1.7 percent gain on Friday in an otherwise tough day on Wall Street.
“Novartis is taking a number of steps to address the urgent needs arising from the COVID-19 pandemic, including the evaluation of our existing therapies to assess if any can be utilized beyond their approved indications,” said John Tsai, head global drug development and chief medical officer, 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. We now are moving rapidly to finalize the study plan and then to enroll eligible patients, as well as put in place a process to provide access for patients unable to participate in the trial.”
Given the spread of the pandemic, and as plans for the study are finalized, Novartis also has set up an international compassionate use program for eligible patients, subject to local regulations.
In addition, we are taking steps to manage the anticipated increase in COVID-19 related requests for Jakavi without interrupting access for patients taking the drug for its licensed indications. In the U.S., access requests are coordinated by Incyte.