A new drug, sabizabulin, which has been clinically tested in the US and other countries (Brazil, Argentina, Mexico, Colombia, Bulgaria), has reduced the death toll of at least half (55%). treated patients with Covid-19 in critical condition, who were receiving additional oxygen and belonged to a high-risk group for severe pneumonia, acute respiratory distress syndrome (ARDS) and death.
The double-blind, randomized, placebo-controlled multicenter clinical trial (phase 3) in a total of 150 patients was discontinued prematurely due to its convincing results, according to biopharmaceutical company Veru, whose stock “took off” on the US Stock Exchange after the announcement. So far, however, no detailed publication of these results has been made, according to the “New York Times”.
There is an urgent need for new treatments for severely ill Covid-19 patients, as new antiviral drugs, such as Merck and Pfizer pills, mainly target patients with mild to moderate symptoms.
In the clinical trial of the new drug, of the 52 patients who received placebo along with standard treatment, almost half (45%) 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 variation, and the drug appears to be equally effective.
The drug, which is administered in capsule form 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. According to Veru, no safety concerns were identified during the clinical trial of the drug, which was tolerated by patients.
“Sabizabulin is the first medicine “which shows a clinically and statistically significant reduction in inpatient deaths, which is a big step forward,” said Dr. Mitchell Steiner, CEO of Veru. As he said, “we are convinced that sabizabulin, thanks to its dual antiviral and anti-inflammatory properties and its now proven efficacy after the phase 3 study, can be this much needed treatment for patients with moderate to severe Covid-19.” .
The US Food and Drug Administration (FDA) issued an emergency drug license in January. The company now plans to ask the FDA for urgent approval for its release. Veru is already planning to upgrade its production capacity to produce the new drug in large quantities due to the expected high demand if it is approved by the FDA.
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