The drug, sabizabulin, has been found to be more effective in helping severely ill Covid-19 patients than previously licensed drugs, researchers report in The New England Journal of Medicine.
True, the Miami-based developer of the drug, has applied to the US Food and Drug Administration for an emergency authorization. Approval would provide another avenue of treatment for hospitalized patients.
“This seems super impressive,” Ilan Schwartz, an infectious disease expert at the University of Alberta, Canada, told the New York Times. “We have a small number of treatments for severely ill patients that improve mortality, but another treatment that can further reduce deaths would be very welcome.”
However, the study sample size was relatively small, as only 134 patients received the drug.
“Overall, I think it’s very exciting, although I would like to see larger, independent confirmatory studies done,” said Schwartz, who was not involved in the study.
The drug prevents cells from building the molecular connections intended to transport materials from one area of the cell to another.
Sabizabulin was initially developed by researchers at the University of Tennessee to fight cancer by cutting off this type of highway access between tumor cells, preventing their rapid growth.
The drug appears to work in Covid-19 patients by reducing lung inflammation, which can be deadly
But the drug appears to work in Covid-19 patients by reducing lung inflammation, which can be deadly.
The trial included patients who were hospitalized for Covid-19 treatment and receiving oxygen or mechanical ventilation. They had other risk factors, such as obesity or high blood pressure, that contributed to their high risk of dying from the disease. For this reason, they were allowed to be treated with other drugs, such as steroids such as dexamethasone, which is said to reduce the risk of death from Covid-19 by a third.
But of the 134 volunteers who took the drug and the 70 who received a placebo, the death rates of the two groups were drastically different after 60 days. More than 45% of the placebo group died compared to 20% of those taking sabizabulin, representing a 55% reduction in the overall risk of death.
A few antiviral drugs have been shown to keep Covid-19 patients out of hospital, but they generally don’t work well with moderate or severe Covid, experts say.
Paxlovid is one such drug that is usually given early in the disease.
True said it stopped the trial early because an independent advisory committee felt the drug was so effective that it would be unethical to continue giving some patients a placebo.