Veru to Advance VERU-111 in P-III Study for COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome

March 2, 2021 Auto Bot advance, Agreement, Clinical Trials, FDA, P-III, receives, Study 0

Shots:

  • The US FDA agreed to advance VERU-111 into a P-III study which will evaluate VERU-111 vs PBO in ~400 hospitalized patients in a ratio (2:1) with COVID-19 and are at high risk for ARDS. The study is anticipated to begin in Apr’2021 with clinical results expected in Q4’21
  • The P-II trial has demonstrated clinically meaningful reductions in relevant endpoints, including respiratory failure, patient mortality, days in the ICU and mechanical ventilation and was well tolerated with a good safety profile
  • The company will seek funding from BARDA to fund the estimated amount of commercial drug to supply the needs of the US population

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Annual Reports

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