Eli Lilly on Wednesday disclosed the first human trial results to be made public for an antibody drug meant to either prevent or treat COVID-19, showing some signs of a potential benefit.
The results come from a Phase 2 study testing people recently diagnosed with mild to moderate COVID-19. One of three studied doses of the drug, developed by Lilly with the biotech AbCellera, met the study’s goal of reducing virus levels by day 11, but the other two, including the highest dose tested, did not.
Lilly also reported treatment appeared to reduce the risk that patients would need hospitalization or seek emergency care, although the finding isn’t conclusive given the relatively small number of participants. Lilly’s drug is one of several antibody treatments now in testing, and its data is the first clinical evidence to emerge suggesting these drugs may be helpful in treating COVID-19.
Much of the attention surrounding coronavirus treatments has focused on vaccines, which have been rapidly advanced through testing and offer the best hope at curbing the pandemic.
But antibody drugs have been developed rapidly as well and their progress may be just as crucial. Though early results for vaccines have shown promise, their ultimate effectiveness is still unclear, particularly for vulnerable groups like older adults. Even if one or more are cleared for emergency use for certain groups within the next six months, immunizing the general population will be a lengthy and difficult task.
Antibody drugs, therefore, could be a bridge to a vaccine. They are engineered to mimic the effects of immune proteins produced by the body to fight infection. Though their potential benefits are temporary, they act quickly and might help keep infected patients or those showing symptoms from getting sicker. They could help prevent infections altogether as well, though obtaining proof of that will take longer study.
Lilly and Regeneron are leading a competitive race that also includes AstraZeneca and partners Vir Biotechnology and GlaxoSmithKline, each testing different variations of antibody drugs in a range of patient groups. Lilly, Regeneron and the team of Vir and GSK are already in late-stage testing.
None of the groups, however, have released data showing whether their drugs are effective, saying only that they’ve been safe enough to move into further testing. That makes Lilly’s disclosure from the BLAZE-1 study a first look at how these drugs may perform.
In the trial, Lilly enrolled symptomatic mild to moderate COVID-19 patients and gave them either a placebo or a low, medium or high dose of its antibody, known as LY-CoV555.
Only patients given the middle dose met the study’s goal measuring change in virus levels from baseline to day 11. Lilly also found most patients, including those on placebo, had cleared the virus by that time point anyway, raising questions about the drug’s potential role.
To better assess effectiveness, Lilly did further analyses that showed its drug improved viral clearance by the third day and reduced the proportion of patients with higher virus levels at later time points, too.
Lilly’s study also tracked whether participants, who enrolled with mild to moderate COVID-19, later needed hospitalization, sought out emergency care or died. According to the drugmaker, 5 of 302 patients treated with its drug were hospitalized or visited the emergency room, compared to 9 of the 150 patients given placebo — a 72% relative risk reduction. The finding isn’t definitive, however, and will need to be verified in larger numbers of patients.
Importantly, Lilly didn’t report any serious side effects related to the drug. No patients, including those on placebo, needed mechanical ventilation or died.
The company did report some evidence of what appeared to be drug-resistant variants of the virus, more commonly in those given the drug than placebo. The possibility of the virus “escaping” antibody treatment is a key concern for developers, which is why some are developing multiple drug regimens that latch onto the virus in multiple ways.
Lilly’s drug is a single antibody, though it revealed Wednesday that it is also testing the drug in combination with another experimental antibody that binds to the coronavirus differently. A larger, “confirmatory” cohort of the BLAZE-1 study, designed to measure reductions in viral load and hospitalizations, is now enrolling.
Lilly plans to soon publish the results in a peer-reviewed journal and discuss next steps with regulators. A second trial, BLAZE-2, is testing whether its antibody can prevent coronavirus infections or COVID-19 in nursing home residents or staff who have been exposed to someone diagnosed with the disease.
Earlier this week, Lilly also reported its approved arthritis drug Olumiant appeared to help speed recovery when used alongside Gilead’s COVID-19 drug Veklury to treat hospitalized patients.