Replies to post #3247 on RedHill Biopharma Ltd (RDHL)

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RedHill Biopharma says oral COVID-19 therapy lowered mortality in hospitalized patients

Feb. 07, 2022 10:59 AM ETRedHill Biopharma Ltd. (RDHL)

By: Dulan Lokuwithana, SA News Editor

Announcing data from a Phase 2/3 trial for its COVID-19 therapy opaganib, RedHill Biopharma (RDHL -2.4%) said Monday that the oral treatment “significantly reduced” death among hospitalized patients who had previously received standard-of-care (SOC).

According to the prespecified mortality analysis, among those who were receiving SOC of remdesivir and corticosteroids, opaganib treated patients were found to have a 70.2% mortality benefit. The second prespecified analysis indicated that the experimental therapy led to a significant 34% benefit in time to recovery.

The company is planning to seek potential regulatory authorizations for the treatment in certain countries in H1 2022, and the regulatory submissions have already begun in the U.S., Europe, the U.K., and additional countries.

In September, RedHill (NASDAQ:RDHL) said that the global Phase 2/3 study for opaganib did not meet the primary endpoint in hospitalized patients with severe COVID-19 pneumonia.