WILMINGTON – Incyte Corp. reported a “disappointing” conclusion Monday to its study of its blockbuster drug Jakafi to fight the effects of COVID-19 in hospitalized patients.
The pharmaceutical company headquartered in Alapocas announced a phase 3 clinical trial study in April to see whether Jakafi, known generically as ruxolitinib, could help reduce the effects of COVID-19 associated cytokine storm, or a severe overreaction of the immune system that can be caused by a viral infection, autoimmune condition, or other disease.
After studying the drug’s efficacy against those who didn’t receive it, however, researchers didn’t find that it lessened the number of patients who died, required ventilation or admission to an intensive care unit. The preliminary finds show that roughly an equal number of patients from the trial and control groups experienced those severe complications.
“Given the urgent nature of the COVID-19 pandemic and the need for treatments for patients hospitalized with severe COVID-19 associated cytokine storm, the results of the RUXCOVID study are disappointing,” said Dr. Steven Stein, chief medical officer at Incyte, said in a statement announcing the findings. “However, we hope that these findings will contribute to the scientific understanding of this complex disease and to the collective efforts of the biopharma industry to find solutions that improve outcomes for patients with COVID-19.”
With the study complete, the data will be further analyzed to determine any potential impact on other studies of ruxolitinib in patients with COVID-19 and will be submitted for publication.
Ruxolitinib is approved by the U.S. Food & Drug Administration 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.
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 was hypothesized that ruxolitinib may be able to play a role in treating these patients, Incyte reported in the spring.
News of the study’s disappointing findings didn’t scare off investors Monday, who were largely pumping up biotech stocks off the news of the Pfizer COVID-19 vaccine’s first administration in the U.S. Incyte shares are up more than 5% today.
