Replies to post #3158 on RedHill Biopharma Ltd (RDHL)

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RedHill Biopharma says its oral COVID-19 therapy cut risk of death by 62% in study

Oct. 04, 2021 8:34 AM ETRedHill Biopharma Ltd. (RDHL)Veeva Systems Inc. (VEEV)

By: Dulan Lokuwithana, SA News Editor

RedHill Biopharma (NASDAQ:RDHL) is trading ~6.2% higher in the pre-market after the company said that in a Phase 2/3 study, its experimental oral COVID-19 therapy opaganib compared to placebo led to a 62% decline in mortality in hospitalized patients with severe COVID-19 pneumonia.

Per the new data disclosed from an analysis of 251 patients, there were seven deaths among 117 patients who received opaganib compared to 21 deaths in the placebo arm consisting of 134 patients indicating a statistical significance of the result with a nominal p-value of 0.019.

Meanwhile, 77% of opaganib-treated patients reached room air by Day 14 compared to 63.5% for placebo (nominal p-value= 0.033).

In addition, those who were treated with opaganib left the hospital early with a median time to discharge of 10 days compared to 14 days for the placebo arm (nominal p-value=0.0195).

The overall adverse events were balanced between the two groups of the study, and no new safety signals were found, the company said.

A conference call is scheduled for Oct. 07 at 8:30 a.m. EDT to present additional data from the Phase 2/3 study.

Veeva Systems (NYSE:VEEV) and Bioforum have partnered with RedHill Biopharma (RDHL) for a global Phase 2/3 study designed to evaluate opaganib in patients hospitalized with severe COVID-19 pneumonia.