Dual Antiviral and Anti-Inflammatory Agent Significantly Reduced Deaths in COVID-19 Patients
Florida-based Veru Inc. announced today positive results from a Phase 3 COVID-19 study evaluating the efficacy and safety of oral sabizabulin, a novel dual antiviral and anti-inflammatory agent, for the treatment of hospitalized moderate-severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS) and death, was published in The New England Journal of Medicine (NEJM) Evidence.
The study's Primary Endpoint, published in a NEJM Original Article on July 6, 2022, showed a statistically significant and clinically meaningful 55.2% reduction in deaths compared to placebo in Moderate-Severe Hospitalized COVID-19 Patients.
"Unfortunately, COVID-19 is here to stay with new variants emerging and rising rates of new cases, hospitalizations, and deaths. The current death rate from COVID-19 infection is unacceptable," commented Alan Skolnick, M.D., Principal Investigator with HD Research, who conducted this Phase 3 COVID-19 study at Memorial Hermann Memorial City Medical Center in Houston, TX, co-author of the NEJM Evidence publication.
And the Key Secondary Endpoints showed that Sabizabulin treatment had a significant and clinically meaningful reduction in Days in ICU, Days on Mechanical Ventilation, and Days in the Hospital rations.
"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 the standard of care treatment received, baseline WHO scores, age, comorbidities, vaccination status, COVID-19 variant, or geography," said Mitchell Steiner, M.D., Chairman, President, and CEO of Veru and co-author of the NEJM Evidence publication, in a press release.
The Company confirmed it previously submitted a request to the U.S. FDA for authorization on June 7, 2022.
The Company stated it has scaled manufacturing and expects to produce sufficient commercial drug supply to address anticipated drug needs following potential FDA authorization in the U.S. and subsequent authorizations in other countries and regions.
Veru Inc. is a biopharmaceutical company focused on developing novel medicines for COVID-19, viral and ARDS-related diseases, and managing breast and prostate cancers.
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