JERUSALEM — When the coronavirus pandemic hit Israel last spring, regulatory officials granted emergency permission to treat some of the sickest patients with a local anti-cancer drug. The six patients dosed with RedHill BioPharma Ltd.’s opaganib, a medicine originally designed for use against bile duct cancer, recovered, and now the therapy is in clinical trials across the world as a potential COVID treatment.
“It’s very exciting,” says Guy Goldberg, chief business officer at RedHill Biopharma, an Israeli company focused on gastrointestinal diseases and infectious diseases that is listed on the Nasdaq. “And we think this could work because it has both antiviral and anti-inflammatory effects.”
The company expects the first trial results in late December, on the heels of this week’s approval in the United Kingdom of a vaccine from U.S.-based Pfizer Inc., which, along with another vaccine from U.S.-based Monderna, is expected to be approved for use in the United States and elsewhere. But those potential vaccines, which would be distributed globally, are not stopping the company’s quest for COVID-19 therapies.
In fact, RedHill is among hundreds of companies continuing to work on COVID-19 treatments, pushing forward the field of virus research in an unprecedented manner, even as vaccines are on the horizon.
“There are still a lot of questions about the vaccines,” says Galia Rahav, head of the infectious disease unit and laboratories at Israel’s Sheba Medical Center. She explains that it is still unclear how long protection from the vaccines would last, how effective they are in elderly people and how they would work on a mutated virus. Even if the vaccines work well, they will also take time to distribute, and surveys have indicated that many people fear them. In the U.S., for example, just 58% of Americans say they would take them, according to a recent Gallup poll. “So there must be treatments, as well,” Rahav says. “But viruses are a little bit tricky to treat.”
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The U.S. Food and Drug Administration has currently registered about 370 clinical trials for COVID-19 therapies. So far, the FDA has only certified one drug — remdesivir — as effective against the novel coronavirus, and granted several others emergency-use authorizations, which are given with less evidence of safety and efficacy that normally required due to the dire health situation.
For all the advances in modern medicine, there are relatively few options for treating viruses, and the treatments that do exist are often specific to the virus, and fail when the virus mutates.
“Viruses change their clothes often,” evading the immune system every cold and flu season, and outsmarting treatments that target them, explains Shruti Gohil, associate medical director of epidemiology and infection prevention at UCI Health in Irvine, California.
RedHill is among those companies trying to change this paradigm, developing a treatment that is effective against COVID-19, but could also work against other similarly structured viruses, including those that cause influenza, Ebola and chikungunya fever, and will also not be affected by any virus mutations. It does this by targeting how the body responds to a virus, rather than the virus itself.
Opaganib blocks the body’s uptake of an enzyme called sphingosine kinase-2, which research shows prevents some viruses, including the novel coronavirus, from replicating. It also prevents the body’s inflammatory response.
“This focus on host-targeting is a very fertile area of research, because it has benefits that don’t exist for classic antivirals,” says Jeffrey Glenn, a professor of medicine, microbiology and immunology at Stanford University, and director and scientific founder of Eiger BioPharmaceuticals. Eiger recently reported trial results showing high levels of safety and effectiveness against mild and moderate COVID-19 for a drug it is developing called Lamba, which could also be used for other viruses, including hepatitis.
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While Lamba, still in trials in the United States and Israel, is a single injection, RedHill’s solution is an oral pill. Both are the types of simple treatments that many experts say is key to controlling the virus because they could be given early on in the disease and don’t require hospitalization like other solutions, including remdesivir, which is given intravenously.
“People are living in fear,” not only because there is no proven treatment, but also because the only patients who do get treated are severe hospitalized cases, says David Sullivan, a professor of molecular microbiology and immunology at Johns Hopkins University. Sullivan is co-leading a trial on giving early stage COVID-19 patients the blood plasma from recovered patients, a process he hopes could become a widely available and simple outpatient procedure.
“If everyone diagnosed could take something right away, people would feel better about going about their lives, going out, going to restaurants, going shopping.”
In addition to dealing with COVID-19, the increased research on anti-virus therapies is key to preventing a future pandemic, something many scientists say is just a matter of time.
“We were caught unprepared this time,” Glenn says. “When we get the next serious pandemic, if we don’t have broad-spectrum antivirals on the shelf, this will be a big problem. A vaccine will never stop a pandemic until it’s too late. We need antivirals to give (out) immediately, to shut it down and stop the spread.”
Meanwhile, the work continues at RedHill and other companies.
“So far, nothing has really worked for COVID,” Goldberg says. “But we are optimistic. And at least there is a lot more interest in these types of therapies now, in things that have been neglected for too long.”
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Coronavirus Pandemic Boosting Anti-Virus Research Around the World originally appeared on usnews.com
