A Durham-based biopharmaceutical company says it has gotten the okay from the Food and Drug Administration to test its experimental cancer drug on COVID-19 patients in the U.S.
The company, Chimerix, believes the drug, originally designed for acute myeloid leukemia, could address lung inflammation in COVID-19 patients as well as blood coagulation issues. The drug, DSTAT, is a derivative of heparin, a blood-thinning agent sometimes given to patients suffering heart attacks.
Heparin can sometimes lead to risks of bleeding at high doses, though, and Chimerix said its drug is able to reduce risks of large bleeding events even at higher dosage points.
Chimerix is hopeful that DSTAT could help solve two complications from COVID-19, said Mike Sherman, the CEO of the company. One, he said, it could reduce damaging inflammation in the lungs, and it could also prevent hypercoagulation, which can cause blood clotting that might cause strokes and pulmonary embolism.
Indeed, there has been a surge in stroke events, especially among young people, in COVID-19 patients, The Washington Post reported this week.
“There are two things that really happen with these patients that advance to the severe form of [COVID-19],” Sherman said in a phone interview. “It is a severe inflammation that creates serious problems and it particularly hits the lungs and then the second is the triggering of this serious coagulation and that comes in many forms like strokes or pulmonary embolism.”
“There are drugs out there that may address the inflammatory response,” he added, “but the unique thing [about DSTAT] is that it may hit both.”
The company, which has around 50 employees in Durham, has quickly moved to test DSTAT in COVID-19 patients, while its trials for the drug in leukemia patients is on hold because of the outbreak. Sherman said that in the cancer tests, DSTAT has been well tolerated by patients.
He said the company has moved at “unprecedented” speeds to test this drug. “We are working around the clock. A Saturday looks just like a Friday,” he said.
The COVID-19 study will be starting in New Orleans but will be expanded to several different sites across the country.
The study is planned for two different phases, and will be randomized, double-blind and placebo controlled. Eligible subjects will be confirmed COVID-19 patients who are hospitalized and require oxygen.
The first phase of the study will look at 24 patients, and will then expand to 74. Depending on results, the last phase could enroll around 450 subjects.
The company is also moving closer to submitting a new drug application to the FDA for a smallpox treatment. Chimerix has been developing a treatment to small pox with funding from the Biomedical Advanced Research and Development Authority, with aims of adding it to the strategic national stockpile.
“The ultimate goal is that will be put into the strategic national stockpile so if there is a small pox outbreak we will be ready for it,” Sherman said. “We stopped vaccinating in the ’70s, so we have lost herd immunity to it. It is on the list of potential threats, whether it is an accidental leak or a bioterror attack.”
Shares in Chimerix were up 61.6% over the last week, up to $2.38 per share, off the back of the news on its smallpox drug and COVID-19 trials. The company reported earlier this year that it lost $112.6 million in 2019, as it continues to invest heavily in research and development but has no drugs currently on the market.
Chimerix joins a wave of biotech companies looking to repurpose drugs in their pipeline as potential treatments for COVID-19.
UNC-Chapel Hill has also helped study the effectiveness of one of the most promising treatments, Gilead Science’s remdesivir, a dug originally made to treat ebola that has shown promise in fighting COVID-19.