Veru’s Stops COVID-19 Treatment Trial in Face of ‘Overwhelmingly Positive’ Results

Veru has stopped a phase 3 study of its COVID-19 treatment sabizabulin after an interim safety analysis found that the drug overwhelmingly reduced the risk of death by 55 percent in patients with moderate-to-severe disease.

The data will form the basis of an Emergency Use Authorization (EUA) application, the company said. Sabizabulin won FDA’s Fast-Track designation in January. Veru said it has already scaled up manufacturing to meet the anticipated need.

Sabizabulin is “the first drug to demonstrate a clinically and statistically meaningful reduction in deaths in hospitalized patients with moderate-to-severe COVID-19,” said Veru’s CEO Mitchell Steiner. “We strongly believe that sabizabulin with its dual anti-viral and anti-inflammatory properties, which demonstrated positive efficacy and safety results in the phase 3 COVID-19 study, can be that greatly needed oral therapy for hospitalized moderate-to-severe COVID-19 patients.”

Sabizabulin prevents the SARS-CoV2 virus from moving through cells on microtubules, the filaments that give cells structure and function as supply highways. Inflammatory proteins also move along microtubules, so by interfering with that structure, sabizabulin helps tamp down the hyperinflammatory response that’s so dangerous in severe COVID-19.

The pivotal trial comprised 210 patients hospitalized with moderate-to-severe COVID-19. They were randomized to placebo or to 9 mg of sabizabulin. Everyone in the study received standard care, including remdesivir, dexamethasone, anti-IL6 receptor antibodies and Janus kinase inhibitors. The planned interim analysis was conducted on the first 150 patients randomized into the study.

The study’s primary endpoint was death by day 60. The death rate in the sabizabulin group was 20 percent compared to 45 percent in the placebo group. That represents a 55 percent reduction in the risk of COVID-19-related death, the company said. Secondary endpoints are still be analyzed.

In addition to filing with the FDA, Veru has been in discussions with the Biomedical Advanced Research and Development Authority (BARDA) to work out a purchasing agreement in advance of any approval actions.

Sabizabulin is also being investigated in prostate cancer and some varieties of breast cancer. — Michele G. Sullivan