<big>interim analysis</big>, published July 6 in NEJM Evidence, on Veru Pharmaceuticals’ oral microtubule disruptor sabizabulin[wik] phase 3 placebo-controlled clinical trial, showed risk for death cut by 55% in hospitalized patients with COVID-19. In preclinical models, Sabizabulin has shown dual antiviral and anti-inflammatory activities. Veru has submitted an emergency use authorization request to the FDA for sabizabulin to treat COVID-19 in appropriate patients.
<big>Abstract</big>
...Methods
A randomized, multicenter placebo-controlled phase 3 clinical trial was conducted with hospitalized patients with moderate to severe Covid-19 who were at high risk for acute respiratory distress syndrome (ARDS) [acute respiratory distress syndrome] and death. Patients were randomly assigned (2:1) to 9 mg of oral sabizabulin or placebo daily (up to 21 days)….
Results
A total of 204 patients were randomly assigned to treatment: 134 to sabizabulin and 70 to placebo. Baseline characteristics were similar. Sabizabulin superiority was demonstrated by a planned interim analysis for the first 150…
Conclusions
Sabizabulin treatment resulted in a 24.9% absolute reduction in deaths compared with placebo in hospitalized patients with moderate to severe Covid-19 at high risk for ARDS and death, with a lower incidence of adverse and serious adverse events compared with placebo. (Funded by Veru, Inc.; ClinicalTrials.gov number, NCT04842747.)
Sabizabulin was originally developed to treat metastatic castration-resistant prostate cancer...The interim analysis (top/first link, bolded) is very interesting beyond the abstract alone. If you don’t get full text going directly there, try via Medscape's write-up (you may need to register to do it, but there’s no pay-wall). From that write-up:
...Sabizabulin treatment consistently and significantly reduced deaths across patient subgroups "regardless of standard of care treatment received, baseline WHO scores, age, comorbidities, vaccination status, COVID-19 variant, or geography," study investigator Mitchell Steiner, MD, chairman, president, and CEO of Veru, said <big>in a news release.</big>...
...Sabizabulin led to a significant 43% relative reduction in ICU days, a 49% relative reduction in days on mechanical ventilation, and a 26% relative reduction in days in the hospital compared with placebo. Adverse and serious adverse events were also lower in the sabizabulin group (61.5%) than the placebo group (78.3%).
The data are "pretty impressive and in a group of patients that we really have limited things to offer," Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America and chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau in Oceanside, New York, told Medscape Medical News. "This is an interim analysis and obviously we'd like to see more data, but it certainly is something that is novel and quite interesting."
David Boulware, MD, MPH, an infectious disease expert at the University of Minnesota, told the New York Times* that the large number of deaths in the placebo group seemed "rather high" and that the final analysis might reveal a more modest benefit for sabizabulin. "I would be skeptical" that the reduced risk for death remains 55%, he noted...
*New York Times articles and larger google search. Readers/commenters may want to add duckduckgo & other search links.