Oral Sabizabulin Reduces COVID-19 Deaths in High-Risk Adults

At 3 years into the pandemic, there are now various effective COVID-19 vaccines and antivirals approved to treat and prevent infection. However, the emergence of new variants and waning of natural immunity and vaccine efficacy means some people, especially the immunocompromised, are still at risk of severe or fatal COVID-19 disease.

COVID-19 morbidity and mortality remain a reality for hospitalized patients at high risk for acute respiratory distress syndrome (ARDS). One study, published in the New England Journal of Medicine (NEJM) Evidence, found the antiviral sabizabulin may significantly reduce COVID-19 all-cause mortality, as well as days in the intensive care unit (ICU), on mechanical ventilation, and in the hospital.

“We have battled this pandemic for two and a half years now, and we are still in desperate need for an effective treatment like sabizabulin to significantly reduce deaths in hospitalized COVID-19 patients,” said Alan Skolnick, MD, who led this study at the Memorial Hermann Memorial City Medical Center in Houston TX and coauthored the NEJM paper. “It’s in the hospital that we have the last real opportunity to prevent deaths from COVID-19 infection.”

Sabizabulin is a novel, oral microtubule disruptor with both antiviral and anti-inflammatory activity. Sabizabulin was developed by the biopharmaceutical company Veru Inc., who requested an Emergency Use Authorization (EUA) application for the drug on June 7.

The randomized, multicenter, placebo-controlled phase 3 clinical trial included 204 patients hospitalized with moderate to severe COVID-19. The study patients were all at high risk of ARDS and death. After randomization, 134 patients received 9 mg of oral sabizabulin and 70 received placebo for up to 21 days.

The patients treated with sabizabulin had a 24.9% absolute reduction and 55.2% relative reduction in all-cause mortality, as compared with placebo. The mortality rate was 20.2% in the sabizabulin cohort and 45.1% in the placebo group.

For the secondary trial endpoints, treatment with sabizabulin reduced ICU days by 43%, mechanical ventilation days by 49%, and days in the hospital by 26%. Additionally, adverse events and serious adverse events were lower in the sabizabulin group than the placebo group.

“This landmark study published in The New England Journal of Medicine Evidence shows the high consistency of sabizabulin treatment to significantly reduce deaths across patient subgroups regardless of standard of care treatment received, baseline WHO scores, age, comorbidities, vaccination status, COVID-19 variant, or geography,” said Mitchell Steiner, MD, chairman, president, and CEO of Veru and coauthor of the NEJM Evidence study.