New antiviral drugs, such as Merck and Pfizer pills, are mostly for individuals with mild to moderate symptoms, therefore new treatments for critically ill Covid-19 patients are urgently needed.

Sabizabulin, a new drug that has been clinically tested in the United States and other countries (Brazil, Argentina, Mexico, Colombia, and Bulgaria), has been shown to significantly reduce the mortality of Covid-19 patients in critical condition by at least half (55 percent) who were receiving additional oxygen and were at high risk for severe pneumonia, acute respiratory distress syndrome (ARDS), and death.

According to biopharmaceutical company Veru, whose stock “took off” on the US Stock Exchange after the announcement, the double-blind, randomized, placebo-controlled multicenter clinical trial ( phase 3 ) in a total of 150 patients was prematurely stopped due to its persuasive results. According to the New York Times, no detailed study of these results has yet been made.

New antiviral drugs, such as Merck and Pfizer pills, are primarily for individuals with mild to moderate symptoms, therefore new treatments for critically ill Covid-19 patients are urgently needed.

In the clinical trial of the new drug, of the  52 patients who received a placebo along with standard treatment, almost half (45 percent) died within the next 60 days, while of the 98 who also received sabizabulin, the percentage deaths were only 20% in the same period. The study involved patients with both Delta and Omicron variants, and the drug appears to be equally effective.

The drug, which is administered once a day (dose 9 milligrams), does not need to be refrigerated and is currently intended for inpatients only. It “works” by preventing the coronavirus from moving to different places inside human cells. At the same time, it “slows down” the overreaction of cytokines in the body, and therefore the excessive inflammation. During the clinical trial of the drug, Veru says, there were no safety issues found. The drug was well-tolerated by patients.

“Sabizabulin is the first drug to demonstrate a clinically- and statistically-meaningful reduction in deaths in hospitalized patients with moderate to severe COVID-19,” said Dr. Mitchell Steiner, CEO of Veru, adding “We strongly believe that sabizabulin, with its dual anti-viral and anti-inflammatory properties which demonstrated positive efficacy and safety results in the Phase III COVID-19 study, can be that greatly needed oral therapy for hospitalized moderate to severe COVID-19 patients.”

In January, the US Food and Drug Administration (FDA) granted an emergency drug license. The company now intends to seek FDA permission for its release as soon as possible. Veru is already working to expand its production capacity in order to meet the anticipated high demand for the new treatment if it is authorized by the FDA.

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