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Novartis, Incyte will take Jakafi into 2nd trial for COVID-19 patients on ventilators

Novartis and Incyte have already pitted their blockbuster JAK inhibitor Jakafi against COVID-19 as a possible treatment for a severe respiratory immune reaction. Now, seeing promise in another category of coronavirus-afflicted patients, the partners will take Jakafi into a second late-stage trial. 

The partners plan to test Jakafi in a second phase 3 trial for COVID-19 patients with acute respiratory distress syndrome (ARDS), the drugmaker announced alongside first-quarter earnings Tuesday.

The U.S. trial will evaluate Jakafi’s safety and efficacy over standard of care in ARDS patients who’ve needed ventilators.

Incyte and partner Novartis announced in early April that they would roll Jakafi—also known as ruxolitinib—into a phase 3 study evaluating its ability to treat cytokine storm, an immune system overreaction that can cause severe respiratory complications. 

The blinded, double-arm study, dubbed Ruxcovid, will evaluate a combination of Jakafi alongside standard-of-care therapy to treat COVID-19 patients with pneumonia, the partners said.

Even with two global clinical studies of Jakafi underway, Incyte said the partners have enough supply of the drug to stave off shortages moving ahead.

“Incyte’s manufacturing processes are proceeding as usual, with increased manufacturing efforts for (Jakafi) in place to respond to the COVID-19 pandemic and study requests,” Incyte said in a release.

Novartis and Incyte immediately rolled out a compassionate use program for Jakafi pending local regulations. Jakafi, which the FDA initially approved to treat myelofibrosis in 2011, is also approved to treat polycythemia vera and chronic graft-versus-host disease.

In the first quarter, Jakafi posted global revenues of $459 million, Incyte said. 

Incyte partner Eli Lilly has also taken rheumatoid arthritis med Olumiant into COVID-19 trials in conjunction with the National Institute of Allergy and Infectious Diseases. 

The Olumiant trial stemmed from an analysis by Benevolent AI, a U.K. artificial intelligence group, that identified the drug as a possible COVID-19 treatment not only for its anti-inflammatory effects, but also an antiviral effect.

Lilly then conducted preclinical studies on its own and discussed the drug’s promise with independent investigators who had tested it in COVID-19. Those early studies featured small sample sizes and weren’t placebo-controlled, so Lilly couldn’t “draw any conclusions.” 

The Lilly-NIAID study was planned to start in April in the U.S., and investigators eventually plan to expand testing to Europe and Asia.