Novel cancer drug halved deaths in hospitalized COVID-19 patientsThe experimental cancer drug sabizabulin slashed all-cause deaths by 55.2% over placebo in high-risk hospitalized COVID-19 patients by 60 days and was tied to fewer adverse events, according to interim results of a randomized, controlled phase 3 trial published yesterday in NEJM Evidence.Scientists from sabizabulin manufacturer Veru, Inc.
led the multicenter trial of the oral drug, which showed both antiviral and anti-inflammatory properties in preclinical models.
The drug binds to the microtubules critical for SARS-CoV-2 cell entry and replication and for the outsized inflammatory response leading to acute respiratory distress syndrome (ARDS) and death.A total of 204 adults with moderate to severe COVID-19 at high risk for poor outcomes were randomly assigned to receive either 9 milligrams of sabizabulin or a placebo daily for up to 21 days.
The trial was stopped early owing to demonstrated drug efficacy, resulting in inclusion of 150 patients (98 assigned to sabizabulin and 52 to placebo) in the analysis, 145 of whom completed the study and had a known status at 60 days.Patients were enrolled at 27 sites in five countries—the United States, Brazil, Bulgaria, Argentina, and Mexico—from May 18, 2021, to Jan 31, 2022.Sabizabulin led to a 24.9-percentage-point absolute reduction and a 55.2% relative reduction in deaths over placebo (odds ratio, 3.23; 95% confidence interval, 1.45 to 7.22).