Drug Developed for Cancer Cuts the Risk of COVID-19-Related Death by Half

A drug candidate developed for cancer treatment containing sabizabulin as its active ingredient and taken in pill form was found to reduce the risk of death by more than 55% in hospitalized COVID-19 patients.

Study investigator and Veru Pharmaceuticals CEO Dr. Mitchell Steiner presented an interim analysis of their phase-3 placebo-controlled trial in a news release. The scientific report of the study was published on 6 July in NEJM Evidence.

Veru submitted a request to the FDA (US Food and Drug Administration) for emergency use authorization of sabizabulin to treat COVID-19.

Targeting Prostate Cancer and Hitting COVID-19

Stage 4 prostate cancer resistant to hormone suppression was the treatment target for which sabizabulin was developed. It is an oral microtubule-disrupting drug with antiviral and anti-inflammatory activity. It has not yet received FDA approval for the treatment of prostate cancer.

Microtubules are protein molecules that form the cellular skeleton, and one of their functions during cell division is to transfer the genetic information belonging to each new cell into the newly formed cells. Sabizabulin prevents cells from dividing by disrupting microtubule function.

Given the mechanism of the drug, researchers at Veru thought that sabizabulin might also help treat lung inflammation in COVID-19 patients (we describe the mechanism of action of the drug in more detail at the end of the article).

NEJM Evidence reported findings from a study of patients at high risk of acute respiratory distress syndrome (SARS) and death, hospitalized with moderate to severe COVID-19. The study involved 150 adults. Patients were randomly assigned to receive 9 mg of oral sabizabulin once daily for up to 21 days (98 patients) or placebo (52 patients).

Overall, among patients hospitalized because of COVID-19, mortality was 20.2% in the sabizabulin group versus 45.1% in the placebo group. Compared with placebo, treatment with sabizabulin resulted in a relative reduction in deaths of 55.2%.

Sabizabulin led to a significant relative reduction of 43% in days in intensive care, a relative reduction of 49% in days on mechanical ventilation, and a relative reduction of 26% in days in hospital compared with placebo.

Adverse and serious side effects were also lower in the sabizabulin group (61.5%) than in the placebo group (78.3%).

In conclusion, these data are quite impressive for patients with severe COVID-19, for whom we have very few truly effective treatment options. However, this is an interim analysis, and clearly the regulatory authorities will want to see more data, but the effectiveness of a drug developed for cancer is certainly something new and quite interesting.

*

Further Reading on Sabizabulin