Gilead to begin trials for inhaled virus medication
The pharmaceutical company that makes the antiviral drug remdesivir, which has shown promise as a treatment for COVID19, will begin trials for an inhalable version of the medication this summer as officials pump up production amid a worldwide push for a cure.
Gilead Sciences, the Foster City company that developed the drug as a potential treatment for ebola, said researchers will begin screening volunteers this week for a clinical trial of the nebulized formula, which is scheduled to start in August.
If it works, the inhalant would be a major breakthrough given that remdesivir is currently given intravenously, which means only hospital patients can receive it. A breathable version could be given to patients at home while the disease is still in its early stages, when the drug
has shown to be most effective.
“For patients who are at high risk of disease progression, it could be particularly beneficial to start treatment outside the hospital,” said Daniel O’Day, Gilead’s CEO. “Our hope is that earlier intervention could help patients avoid hospitalization altogether.”
In an open letter announcing the U.S. Food and Drug Administration’s approval of the planned trial, O’Day said that by waiting to administer the drug in the later stages of the disease, “the body’s inflammatory response may cause some of the most lifethreatening aspects.”
The inhaled formulation would be given through a nebulizer — which generally means patients put on a mask attached to a machine that allows them to breathe the medicinal fumes.
If remdesivir proves to be effective in an inhalable form, “that would be a game changer,” said Dr. Lee Riley, a UC Berkeley infectiousdisease expert.
That’s in part because it would allow people to administer the drugs themselves before they need to go to the hospital.
“Not only could that reduce the chances of hospitalization, but even if they end up getting hospitalized, they may not have to stay in the hospital for a long time,” Riley said. “The other major advantage is if they can start treating themselves early, then that would also reduce the chances of transmission.”
However, Riley also cautioned that administering the drug through a nebulizer could also aerosolize the virus, meaning it would be carried through the air. He said that’s something the study should monitor.
Remdesivir interferes with the process the coronavirus uses to replicate itself in human cells in order to reduce the severity of infection. Gilead has been authorized to provide the drug to the government for distribution to hospitals to treat severely ill patients under the Emergency Use Authorization Act.
Although remdesivir wasn’t particularly effective against ebola during trials, it was the first drug to show success against COVID19. More than 250 treatments for the disease are being studied worldwide.
Hospitalized patients who received remdesivir intravenously recovered faster than those who received a placebo during a large study led by the federal government in late April. A later trial investigating dosages showed some benefit for moderately ill COVID19 patients who received remdesivir for five days, but improvement among those who got it for 10 days was not statistically significant.
Researchers believe that some of the more severe symptoms during later stages of the disease are tied more to the body’s immune response than the virus itself — making an inhalable form of remdesivir particularly attractive.
“There’s reason to believe that if there were a way to give it ... earlier than it’s currently given, then it would be more effective, because its target is viral replication,” said Dr. Robert Siegel, an infectiousdisease expert at Stanford University. “It’s possible that, by earlier treatment, we might be able to avert the most dangerous effects of the infection.”
In addition to the nebulizer trial, the company is launching another trial in more than 30 locations in the U.S. and Europe to see how remdesivir works on 50 pediatric patients, from newborns to teenagers, with moderate to severe COVID19 symptoms. Studies of how the disease impacts pregnant women and ethnic minorities are also in the works.
Besides the inhalant, O’Day said the company will also be studying intravenous infusions in outpatient settings, like nursing homes.
Gilead researchers are also combining remdesivir with antiinflammatory therapies in an effort to tamp down overreactive immune responses that doctors believe are responsible for some of the more severe problems, like acute respiratory distress syndrome, or ARDS, which has killed more people than any other complication connected to the disease.
Among the drugs that will be tested in combination with remdesivir are baricitinib and tocilizumab, both of which tamp down inflammation caused by the human immune system. O’Day said the company has accelerated production of the drug and now expects to have more than 2 million remdesivir treatment courses available by the end of the year.
Gilead, which is valued at about $100 billion, has previously come under fire for its pricing, particularly for its HIVprevention drug Truvada. O’Day promised to do everything he can to make the drug accessible and affordable to governments around the world.
“Our best hope of beating COVID19 is with a set of tools at our disposal: complementary therapeutics, effective vaccines and widespread testing,” O’Day said. “Having already seen that science can deliver answers, we can be hopeful of continued progress. Gilead will do all it can to help drive that progress by exploring the full potential of remdesivir.”