Veru's COVID-19 Drug Candidate Shows High Relative Reduction In Treatment Failures, Mortality In Mid-Stage Study

Veru Inc (NASDAQ: VERU) rises sharply after announcing positive efficacy and safety results from a Phase 2 trial evaluating VERU-111 versus placebo in approximately 40 hospitalized patients at high risk for Acute Respiratory Distress Syndrome from SARS-CoV-2.
Data showed that VERU-111 treatment compared to placebo had a statistically significant and clinically meaningful reduction in the proportion of treatment failures with a 30% treatment failure rate in the placebo group compared to a 5.6% in the VERU-111 treated group at Day 29.
Analysis of greater than 60 years of age diagnosed with COVID-19 who are at higher risk for death and respiratory failure, treatment failures were 9% for VERU-111 versus 50% for placebo. The severity of COVID-19 in hospitalized (on oxygen) patients and treatment failures was 11% for VERU-111 versus 54% for placebo.
VERU-111 reduced the proportion of patients who died in the study from 30% in the placebo group to 5.3% in the VERU-111 treated group. A statistically significant and clinically meaningful reduction in ICU days and reduced mechanical ventilation days was observed in the VERU-111 treatment arm, compared to placebo.
FDA has granted an expedited end-of-Phase 2 meeting to Veru to discuss the next steps, including a Phase 3 registration trial design for the VERU-111 COVID-19 program. The planned 200-subject pivotal trial will have a similar trial design to the Phase 2 study with the primary efficacy endpoint of the proportion of patients alive without respiratory failure at Day 29. Once approved by the FDA, the Phase 3 trial could begin in April and conclude by the end of 2021.
The company will seek funding from the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services and other agencies.
Veru will host a conference call today at 9:00 am ET.
Price Action: VERU is up 16.8% at $12.72 during premarket trading on the last check Monday.

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