A drug being developed by Eli Lilly helped sick patients rid their systems of the virus that causes Covid-19 sooner and may have prevented them from landing in the hospital, according to newly released data.
The drug is what is known as a monoclonal antibody, which experts view as being among the most likely technologies to help treat Covid-19. It’s a manufactured version of the antibodies that the body uses as part of its response to a virus.
“This is a good start,” said Eric Topol, the director and founder of the Scripps Research Translational Institute. “A lot is pinned not only on Lilly but on the whole family of these [monoclonal antibodies], because even though they’re expensive and they’re not going to make a gajillion doses, they could make a big difference in the whole landscape of the pandemic.”
Lilly, which is developing the drug with the biotechnology firm Abcellera, tested three doses of its antibody against placebo in a trial enrolling about 450 patients recently diagnosed with mild to moderate Covid-19. The middle dose, 2,800 mg, met the trial’s primary goal of significantly reducing patients’ levels of SARS-CoV-2 after 11 days.
But other doses of the drug did not meet that goal, including a higher dose of 7,000 mg and a lower one of 700 mg. That could raise the risk that the benefit was due to chance, because normally one expects a medicine to become more effective as the dose increases, known as a dose response.
In a statement, Lilly said the problem may have stemmed from how the study chose to assess how much virus was detectable after 11 days. Most patients, including those who received placebo, had almost no virus at that time point. The company said that an analysis at day three showed the lower viral levels among those who received the antibody.
In a more tantalizing finding, the medicine also appeared to reduce patients’ odds of ending up in the hospital. Just 1.7% of patients who received the drug, called LY-CoV555, eventually went to the emergency room or were hospitalized, compared with 6% of those who took placebo. That amounts to 72% relative reduction in risk.
Those hospitalization data, though, are from a small number of patients, again increasing the odds that the finding won’t hold up with further study. Five of 302 patients on LY-CoV555 were hospitalized, compared to nine of 150 patients who received placebo. Lilly declined to confirm the difference is statistically significant, citing the need for full publication of the results.
“This is extremely exciting, and maybe a pivotal moment in the fight against Covid-19, said Daniel Skovronsky, Lilly’s chief scientific officer. “I think this should give us confidence that neutralizing antibodies are going to be an important part of the solution for ours and other companies, and that we will win the fight against Covid-19 through medicine and innovation.”
Skovronsky noted that studies of the antibody began only six months ago, and said that, although two doses missed on the 11-day endpoint, the antibody’s impact on symptoms and hospitalization gave him confidence in the result. He said that Lilly will share the results with regulators such as the Food and Drug Administration, and hoped to have discussions about a possible emergency use authorization (EUA).
“We will be discussing with regulators what the appropriate next steps are,” Skovronsky said. “So, of course, those discussions will include additional clinical trials as well as other options such as EUA. It’s a small dataset for sure, we we have 450 patients in this data set, but the magnitude of the impact on a hard end point years is very exciting and potentially meaningful for patients.”
Topol said that he does not think an EUA would be justified. “I don’t think it would qualify to even consider that,” he said. “That’s encouraging but that’s different from saying it’s ready for emergency approval.”
The antibody led to no serious side effects, Lilly said, and adverse reactions were similar among patients regardless of whether they received placebo or any dose of LY-CoV555.
The results, which have not been peer reviewed, came from an interim analysis of an ongoing study. The trial, called BLAZE-1, will also test a second antibody in combination with LY-CoV555 and enroll about 800 patients in total. Lilly has promised to publish all of its results in a peer-reviewed journal at a later date.
Lilly is conducting larger tests of the antibody, including one study in using the antibodies to prevent infection in nursing homes that is using recreational vehicles to provide on-site hubs for running the clinical trial. That study is being run with the National Institute of Allergy and Infectious Disease.
So far, only a handful of drugs have shown a benefit in randomized controlled trials against Covid-19. Those include remdesivir, developed by Gilead, and the steroid dexamethasone, as well as the baricitinib, another Eli Lilly drug, which the company said Monday sped improvement of hospitalized patients by one day in a study being run with NIAID.
Regeneron Pharmaceuticals, which is developing a combination of two antibodies to treat Covid-19, is expected to have preliminary data from a placebo-controlled trial later this month. Like Lilly, Regeneron’s antibodies are designed to target a key protein on the surface of SARS-CoV-2 that allows the virus to enter human cells and replicate.