Drug candidate holds promise for treating breathing-related symptoms caused by COVID

Potent Pill

While the vaccines against the COVID-19 virus may have helped to turn the corner on the pandemic, large numbers of people around the world are still unvaccinated and are continuing to contract and suffer from COVID viral infection. Moreover, new variants of the virus are emerging, and we cannot be sure that the vaccine will protect us for all of them. Treatments against COVID remain critical. According to Sharron Wrobel, writing in Algemeiner, the Israeli drug company RedHill Biopharma has produced a promising new COVID therapy that is now finishing up its clinical trials. 

As Guy Goldberg, chief business officer at RedHill Biopharma, explained, “Delta variants are scaring everyone, rightfully so, and more and more people are nervous about what’s going to happen. Vaccines are being less and less effective than we thought as the rate of infection is becoming higher and higher. It is not just the question of people who are unvaccinated. This is an emerging story, and one that threatens to bring the whole world back to square one. The need for therapeutics is as strong now as it ever has been during the pandemic, and there is not enough innovation out there.”

The drug, called Opaganib, is both anti-inflammatory and anti-viral, so that it works on both the cause and the effects of COVID infection. As an oral agent, it is easier and faster to dispense to patient than an injectable. 

Goldberg added, “A lot of the drugs out there only work on the inflammation, or they only work on the virus. Both aspects of it need to be addressed because you can have a virus spiraling out of control if you only notice the symptoms, the virus will continue to do damage. On the other hand, if you only address the virus, the inflammation cascade can get out of control, and you can still have a very sick patient get worse, even though you really have the virus under control.”

Rather than attacking the virus, the drug enters the cells of the patient’s body, keeping the virus out of the cell so that it cannot reproduce. It is thus non-specific toward different strains of the virus and is expected to be active against new variants that are emerging or may emerge in the future.

“Our dream is that we meet our primary endpoint which is having patients weaned off oxygen in a statistically significant way,” Goldberg said. “The virus mutates, so there are changes in the virus by protein and the drug might be less effective because now the target is changed — so it might have been effective against the earlier variants, but the new variants are different in the way it is designed to attack the virus.” 

Opaganib was tested in late-stage Phase 2/3 randomized double-blind clinical trials involving 475 patients suffering from pneumonia derived from COVID infection. After 2 weeks of therapy, patients with severe COVID infections and who had been receiving oxygen were able to leave the hospital.

According to William Severson, director of shared resources for the Center for Predictive Medicine at the University of Louisville, “The results we have seen with Opaganib so far are exciting. They provide further evidence in support of Opaganib’s antiviral capabilities and highlight Opaganib’s potential as an orally-administered treatment for COVID-19 and its continuously emerging variants.”

Goldberg added, “Without Opaganib you would expect about a third of them to progress onto mechanical ventilation time, so the fact that all of them were discharged is a very good response. So this is just compassionate use, but it’s anecdotal.”

Opaganib has already received orphan drug designation from the US Food & Drug Administration (FDA) for off-label use in treating some cancers. It could get emergency- use approval if the studies show that it is safe and effective.

“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. This makes the completion of this study even more significant, given its potential to be a game-changer in the treatment of COVID-19,” concluded Mark L. Levitt, MD, Ph.D., medical director at RedHill. “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.”