RedHill Biopharma Ltd. announced new data from a prespecified analysis of all oral opaganib's[1] Phase 2/3 study patients with positive PCR at screening, demonstrating that opaganib improved the median time to viral RNA clearance by at least 4 days. Treatment with opaganib resulted in viral RNA clearance in a median of 10 days while the median for clearance in the placebo arm was not reached by the end of 14-days treatment for placebo (Hazard Ratio 1.34; nominal p-value=0.043, N=437/463). Opaganib was studied in a global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840) with positive PCRs at screening obtained for 437 out of 463 patients (the remaining patients could not be included in this prespecified analysis due to lack of PCR results at screening).

Results from a post-hoc analysis of data from 251 study participants requiring a Fraction of inspired Oxygen (FiO2) up to and including 60% at baseline (54% of the study participants) demonstrated that treatment with oral opaganib resulted in a 62% reduction in mortality as well as improved outcomes in time to room air, median time to hospital discharge, and likelihood of intubation and mechanical ventilation in this large group of hospitalized, moderately severe COVID-19 patients.