A simple pill to treat COVID-19? Israeli pharmaceutical company may have potent formula as fears of variants grow

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Laboratory work in the facilities of RedHill Biopharma. Photo: RedHill Biopharma

As concerns about rapidly spreading coronavirus variants continue among even highly vaccinated populations, an Israel-based pharmaceutical company is hoping its oral drug candidate will help COVID-19 patients withdraw from oxygen more quickly.

RedHill Biopharma says there are only a few weeks left to pass a watershed to show the effectiveness of its drug candidate, opaganib, in treating patients with severe respiratory symptoms caused by the coronavirus.

“The Delta variants are rightly scary for everyone, and more and more people are nervous about what’s going to happen. Vaccines are less and less effective than we thought because the infection rate is higher and higher, ”said Guy Goldberg, Commercial Director of RedHill Biopharma. The Algemeiner in an interview.

“It’s not just the issue of people who are not vaccinated. It’s an emerging story that threatens to bring the whole world back to square one, ”he said. “The need for therapy is as strong as it ever was during the pandemic, and there is not enough innovation. “

A chemical entity, opaganib is an inhibitor that acts on both the cause and the effect of COVID-19. It has a dual mechanism of action as it is anti-inflammatory and antiviral, which society hails as a great differentiator with other treatments.

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

As an oral pill, the drug may be easier to prepare, administer, and dispense than injectable treatments like Gilead Science’s remdesivir.

Earlier this week, RedHill Biopharma completed the randomized, double-blind, placebo-controlled Phase 2/3 clinical trial in 475 patients with severe COVID-19 pneumonia conducted in Israel and other countries including Brazil and in Europe.

Goldberg said the company is weeks away from the results and if they are positive the treatment could be a “game changer” for more severe cases of the virus.

“Our dream is that we meet our primary endpoint, which is that patients are weaning off oxygen in a statistically significant way,” he said.

Goldberg argued that drugs like remdesivir might have more limited effectiveness when it comes to variants, which are spike protein mutations, because they primarily attack the virus specifically.

“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 could have been effective against the previous variants, but the new variants are different in their way. way of being, designed to attack the virus, ”Goldberg said.

Opaganib acts on the body cell rather than directly on the virus, he said, preventing “the host from allowing the virus to enter the cell, and it stops the virus from replicating and spreading. the infection”.

In collaboration with the Center for Predictive Medicine at the University of Louisville, opaganib was studied in a 3D tissue model of human bronchial epithelial cells to assess the in vitro the efficacy of opaganib in inhibiting beta, which is the South African variant of SARS-CoV-2, and Gamma, the Brazilian variant. Preliminary results showed a potent inhibition of both variants by opaganib at non-cytotoxic doses.

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

The study was carried out before the widespread emergence of Delta, the Indian variant, but the researchers hope that the drug will maintain its effect against this variant, due to the same mechanism of action.

The Delta variant now accounts for 83% of all new U.S. cases of coronavirus disease, while recent data from Israel suggests that the efficacy of the Delta variant vaccines may be lower than previously thought .

Additionally, RedHill Biopharma has reported “positive results” after making the drug available for compassionate use in hospitals in Israel and Switzerland. After 14 days of therapy, hospital patients with severe COVID-19 infection, who required supplemental oxygen, were discharged from the hospital.

“Without opaganib, you would expect about a third of them to go through mechanical ventilation time, so the fact that they were all unloaded is a very good answer,” Goldenberg said. “So it’s just compassionate use, but it’s anecdotal. “

If the study results show the drug to be safe and effective, they could open the door to emergency use approval in the United States through the Food and Drug Administration. Agreements with other regulators around the world could then be next, with possible interest in places like India, South America, Brazil and South Africa.

“The advantage of being a small molecule is that you are a lot cheaper to make and therefore you can also sell it for a lot less money,” Goldberg said.


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