Results pending as RedHill Biopharma concludes phase 2/3 COVID-19 study of oral opaganib

A phase 2/3 study that put oral opaganib to 475 patients hospitalized with severe COVID-19 affiliated pneumonia concluded this week, and its creator, RedHill Biopharma Ltd., said that top-line results are expected to follow in a matter of weeks.

“Emerging data is showing that variants are capable of evading vaccines’ effects. Not only does this threaten efforts to control the pandemic, but it also brings into sharp focus the urgent need for effective oral COVID-19 therapies capable of working despite the emergence of variants,” Dr. Mark Levitt, medical director at RedHill, said. “This makes the completion of this study even more significant, given its potential to be a game-changer in the treatment of COVID-19. We can now concentrate on getting all the data collected, cleaned, and collated in the database ready for analysis and subsequent reporting. This means we are weeks away from knowing if we are a big step closer to having a paradigm-shifting oral therapy for hospitalized COVID-19 patients.”

Opaganib is a host-targeted, dual antiviral and anti-inflammatory pill currently being examined as a treatment for severe COVID-19 cases, which has also shown possibilities for anticancer activity. It has demonstrated some efficacy as an in vitro method against Beta and Gamma variants of the SARS-CoV-2 virus. RedHill has cited preliminary results from this latest study as signs opaganib could maintain activity against other emerging variants, such as Delta and Delta Plus.

Delta now makes up 83 percent of all new U.S. cases of the disease, according to Centers for Disease Control and Prevention (CDC) DIrector Dr. Rochelle Walensky, who made this revelation in a Senate committee hearing this week.

The primary endpoint of the global opaganib Phase 2/3 study was the proportion of patients breathing without oxygen support by day 14 of treatment. Researchers also studied the time to hospital discharge, as well as improvement and incidences of intubation and mortality. As many as four independent Data and Safety Monitoring Board recommendations have been filed urging continuation of the study following three unblinded safety reviews and an unblinded futility analysis.

Earlier, a Phase 2 study of 40 participants saw half reach breathing free of oxygen support by day 14, compared to a mere 22 percent of those in the placebo group. Further, 86.4 percent of patients treated with opaganib were discharged by that time, as opposed to just over half (55.6 percent) of patients treated with placebo.

The latest study results could potentially guide the drug’s pathways to approval through the U.S. Food and Drug Administration (FDA), among others. Presently, the opaganib operates on an Orphan Drug designation from the FDA for the treatment of cholangiocarcinoma.