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U.S. FDA Considers Another COVID-19 Antiviral

October 13, 2022 • 4:00 pm CDT
by Cdu 445
(Precision Vaccinations News)

Veru Inc. today announced that positive data from the Phase 3 trial of sabizabulin for hospitalized moderate to severe COVID-19 patients who required supplemental oxygen has been accepted as a late-breaker oral presentation on October 19-23, 2022, in Washington, D.C.

Treatment with sabizabulin 9 mg once daily, an oral, first-in-class, new chemical entity, microtubule disruptor with dual anti-inflammatory and antiviral properties, resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths compared to placebo.

Based on a planned interim analysis of the first 150 randomized patients, the Independent Data Monitoring Committee unanimously halted the study for clear clinical efficacy, and no safety concerns were identified.

Additionally, the U.S. FDA has informed the Company that FDA’s Pulmonary-Allergy Drugs Advisory Committee will meet on November 09, 2022, to discuss the Company’s sabizabulin for COVID-19 request for emergency use authorization.

Sabizabulin is an orally bioavailable bis-indole that binds to the “colchicine binding site” of alpha and beta tubulin and inhibits tubulin polymerization at low nanomolar concentrations.

Sabizabulin disrupts the microtubules, the central mechanism contributing to their antiviral and anti-inflammatory activities.

Drugs like sabizabulin that target microtubules have broad antiviral activity by disrupting the intracellular transport of viruses such as SARS CoV-2,

Previously, Australia’s Therapeutic Goods Administration determined on August 22, 2022, that sabizabulin treatment in hospitalized COVID-19 patients at high risk for ARDS qualifies for an expedited, provisional registration regulatory pathway.

Other COVID-19 antiviral news is posted at PrecisionVaccinations.

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