An experimental COVID drug was so successful that they’re shutting down trials early
A new drug could be a godsend for patients hospitalized with COVID, and help save the most critical cases.
A double-blind study that ended last week showed that sabizabulin, a new oral medication from pharmaceutical company Veru has the potential to cut the virus’s mortality rate in half for moderate and severe cases. It was so successful, in fact, that researchers stopped the trial early.
“What that implies is that it’s unethical to continue treating people with placebo,” Mitchell Steiner, chairman, president, and CEO of Veru, told Fortune.
While the study was originally meant to involve around 210 patients hospitalized with COVID, an early analysis of the first 150 patients showed such overwhelming success that the study’s independent data monitoring committee recommended halting it. The group of people who took the placebo pill had a 45% mortality rate, while the sabizabulin-treated group had a mortality rate of just 20%.
Sabizabulin functions as both an antiviral and anti-inflammatory drug that targets cellular infrastructure known as microtubules. The coronavirus uses that infrastructure to travel into cells where it replicates before traveling out again to spread.
“We disrupt that,” says Steiner, adding that sabizabulin blocks both the virus and its associated inflammatory proteins.
Steiner says that the 45% mortality rate seen in the placebo group of the sabizabulin trial has been largely consistent for patients with severe COVID since the start of the pandemic.
“That’s scary to think, that by the time you get into the hospital and you’re on oxygen, you have a fifty-fifty chance of surviving,” says Steiner. “This takes some of the scariness out of going to the hospital.”
Most COVID restrictions have disappeared across the U.S., and as the pandemic stretches into its third year, many Americans have tired of constantly being on guard. But there are still approximately 500 COVID-related deaths on average in the country every day, and Dr. Anthony Fauci has predicted a new wave coming this fall, with a potential increase over the next few weeks.
Because of the persistent need for effective treatment for severe COVID, the third phase of Sabizabulin’s trial received “fast track” designation by the Food and Drug Administration (FDA) in January.
Veru is currently seeking emergency-use authorization of sabizabulin from the FDA, which a previous COVID treatment, remdesivir, received in May 2020. That means the drug could be available in just a few months.
The FDA declined Fortune’s request to comment, stating that it “cannot comment on pending applications before the agency or its interactions with any manufacturers about their investigational products.”
Beyond mortality data, Veru is studying other positive effects that sabizabulin might have, including cutting down the number of days a patient stays in the ICU, and the number of days a patient is on mechanical ventilation.
And although the company is currently testing a COVID treatment, Veru’s area of expertise is oncology research, with a focus on breast and prostate cancers. Steiner says the company was previously researching sabizabulin for its cancer-fighting properties before it began pandemic research.
“We’re an oncology company and we happened to fall into the virus world because we’re in the middle of a pandemic, and we felt duty-bound,” he said.
Steiner likens the race to find an effective treatment for severe COVID to the U.S. space program during the 20th century, which spawned “new technologies that had nothing to do with space” but found other applications.
He says he’s confident the drug will ultimately win approval from the FDA, especially considering the fact that it did not trigger any safety concerns during testing.
Veru is currently in discussions with the Biomedical Advanced Research and Development Authority (BARDA) and other government agencies to secure an advance purchasing agreement for the drug, pending approval from the FDA.
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