RedHill Biopharma Ltd (RDHL)

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RedHill Biopharma says trial for COVID-19 therapy did not meet endpoint

Sep. 14, 2021 8:32 AM ETRedHill Biopharma Ltd. (RDHL)

By: Dulan Lokuwithana, SA News Editor

Announcing preliminary topline data from a global Phase 2/3 study, RedHill Biopharma (NASDAQ:RDHL) said the study for opaganib (ABC294640) in patients hospitalized with severe COVID-19 pneumonia did not reach its primary endpoint.

However, without statistical significance, the study efficacy endpoints showed favorable trends for opaganib arm compared to placebo across multiple endpoints, including the primary endpoint, the company added.

The adverse events were balanced across both arms of the study, and topline safety data indicated a good tolerability profile for opaganib.

The analysis of topline data is ongoing, and RedHill Biopharma (RDHL) intends to discuss the results with the FDA and other overseas regulators for a potential path forward.

“While we are disappointed with the data not reaching statistical significance, we do see a trend that needs to be investigated that opaganib may provide benefit to patients earlier in the course of the disease,” CEO Dror Ben Asher noted.