On April 11, Veru Inc. (VERU) announced game-changing clinical study results for its Covid-19 oral drug candidate, sabizabulin. Consequently, investors rallied towards the stock to make it soar by a mammoth 182.30% during the regular session. Continuing its bullishness into the after-hours, VERU reached $13.95 after closing the prior session at $12.28. Thus, the stock added a further 13.60% in the after-hours trading on Monday.
VERU’s Game-Changing Results
The company had been conducting a Phase 3 Covid-19 clinical trial of its oral candidate sabizabulin in 210 patients against a placebo. The trial is designed to evaluate the efficacy and safety of the drug in hospitalized patients at high risk of ARDS (Acute Respiratory Distress Syndrome). Moreover, the primary efficacy point of the trial was the proportion of patients’ death by Day 60.
As per the plans of the trial, VERU conducted an interim analysis after the first 150 patients were randomized into the study. The interim analysis proved to be game-changing as the drug reduced death by a staggering 55% while no safety concerns were identified. Given the overwhelming efficacy, the Independent Data Safety Monitoring Committee unanimously halted the trial. Additionally, a further huge plus point of the drug candidate is the independence of its pharmacological activity of Covid-19 variant types.
Currently, the company is planning to meet with the FDA for discussing the next steps including submitting an emergency use authorization application. The recently granted Fast Track designation is expected to help with the EUA.
Furthermore, the secondary efficacy endpoints are under analysis as of now. The production plans for commercial drug supply are in place as well.
The potential of the company’s Covid-19 drug candidate proven by the latest data set is game-changing. Sabizabulin is the first drug to demonstrate a clinically and statistically meaningful reduction in deaths in hospitalized patients.
Up to 20% of Covid-19 patients develop severe disease which requires hospitalization. The hospitalized patients are at great risk of developing ARDS. ARDS is one of the most common clinical manifestations of severe Covid-19, which is also one of the main causes of high mortality in the patients. Thus, VERU’s drug candidate if and when approved would prove extremely meaningful in the possible next wave of Covid-19 as the U.S among other countries progress towards the winter cycle.
VERU stock is enjoying some nice gains on the positive data of the Covid-19 drug candidate. With the possible EUA in sight, the drug would prove a game-changer for hospitalized patients due to Covid-19.