The new drug, which is undergoing pilot and clinical trials in many countries, has reduced the critical mortality of Covid-19 patients by at least half (55%).
Trials were conducted on volunteer patients who were prescribed it in the US, Brazil, Argentina, Mexico, Colombia, and Bulgaria. All of them, among other things, received supplemental oxygen and were at high risk for severe pneumonia, acute respiratory distress syndrome (ARDS), and they faced a poor outcome.
Sabizabulin was tested on 150 patients. However, its trials were terminated prematurely due to their convincing results, said Veru, a biopharmaceutical company that developed the drug and whose share on the US stock market skyrocketed after the announcement.
However, so far there was no detailed publication of the results, according to the New York Times. There is an urgent need for new treatments for critically ill patients with Covid-19 as antivirals such as Merck and Pfizer tablets, mainly intended for patients with mild to moderate symptoms.
The drug is also effective in the treatment of various strains of covid. In a clinical trial of a new drug, of 52 patients who received placebo along with standard treatment, almost half (45%) died within the next 60 days, while of 98 patients who received sabizabulin, the percentage of deaths was only 20% in the same period. The study included patients with both Delta and Omicron covid strains. The drug was equally effective in both cases.
The drug is taken in capsule form once a day (9 mg dose), does not need to be refrigerated, and is currently reserved for hospitalized patients only. It prevents the coronavirus from moving to different places inside human cells. At the same time, it “slows down” the over-reaction of cytokines in the body and thus the over-inflammation. According to Veru, during clinical trials of the drug, no problems or side effects were identified.
“Sabizabulin is the first drug to demonstrate a clinically and statistically significant reduction in inpatient mortality, which is a major step forward,” said Dr. Mitchell Steiner, CEO of Veru. “We are convinced that sabizabulin, due to its dual antiviral and anti-inflammatory properties and proven efficacy after Phase 3 study, may be a much needed treatment for patients with moderate to severe Covid-19.”
In January, the US Food and Drug Administration (FDA) issued an emergency drug license. The company now plans to seek urgent approval from the FDA for its release. Veru is already planning to upgrade its manufacturing facilities to produce the new drug in large quantities due to expected high demand if it gets approved by the FDA.