- 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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