A Delaware-based biopharmaceutical company has the go-ahead from the Food and Drug Administration (FDA) to test one of its drugs as a possible COVID-19 treatment.
Officials at Incyte in Wilmington are moving forward with clinical trials of Jakafi—or more commonly ruxolitinib. The drug is used to treat blood cancers among other things and made Incyte almost $1.7 billion last year.
The study seeks to determine if ruxolitinib can inhibit what is called a cytokine storm. Cytokine storms occur in some COVID-19 patients when the body’s defense systems go overboard and attack the lungs—creating the inflammation that leads potentially to pneumonia and the need for a ventilator.
“So it’s actually the body’s overactive immune system that creates most of the problem with COVID-19 infection,” said Incyte’s group Vice President of Oncology Targeted Therapeutics Peter Langmuir, MD. “So our study is designed to try to show that ruxolitinib can block that inflammation and block many of the severe side-effects of COVID-19 infection.”
The randomized controlled study will enroll about 400 patients in the US and Europe. It will be conducted in concert with Novartis, the company that owns the international rights to the drug.
“The primary endpoint of that study will be the proportion of patients who either die, who develop respiratory failure or require intensive care unit stay before day 29,” said Langmuir.
The FDA also approved Incyte’s expanded access program to make ruxolitinib available to patients with severe COVID-19 symptoms who may benefit from the drug while the clinical trials are being conducted.
“We would like to make sure that physicians have the ability to treat their patients with ruxolitinib even if they can’t enroll in the phase three clinical trial,” said Langmuir. “So we will make that available to sites throughout the United States.”
Langmuir says Incyte is working locally in Delaware to make the drug available through the expanded access program.