Potential for two-pronged action against COVID-19 as an antiviral and anti-inflammatory agent supported by Phase 2 clinical study results –
– Primary efficacy endpoint in hospitalized patients shows VERU-111 treatment had statistically significant 81% relative reduction in death or respiratory failure at Day 29 –
– Statistically significant 82% relative reduction in patient mortality versus placebo–
– Statistically significant reduction in days in ICU; there was also a decrease in days on mechanical ventilation–
– Oral daily dosing well tolerated with no treatment-related adverse events –
– Granted expedited meeting with FDA to discuss Phase 3 trial design and meeting with BARDA to discuss potential funding; Phase 3 clinical study expected to begin in April 2021 with clinical results expected in calendar Q4 2021 –
– Company to host an investor conference call at 9:00 am ET today to discuss results and next steps –
Veru Inc. will host a conference call today at 9:00 am ET to discuss the positive clinical results from the Phase 2 trial. Interested parties may access the call by dialing 1-412-902-6703 and entering the participant access code number 1310812 to enter the conference. The call will also be available through a live audio broadcast via the Internet at www.verupharma.com. A playback of the call will be archived and accessible on the same website for at least three months. A telephonic replay of the conference call will be available later that day by dialing 1-877-344-7529 for U.S. callers, or 1-412-317-0088 from outside the U.S., replay access code 10152256, for one week.
https://finance.yahoo.com/news/veru-reports-positive-phase-2-123000247.html
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