Eli Lilly and Co. says early data from its mid-stage trial of an antibody therapy shows it is safe and may reduce some symptoms of coronavirus disease.
It’s one of several so-called monoclonal antibodies being tested in coronavirus patients. These are lab-engineered immune system particles designed to home in on specific parts of the virus. LY-CoV555 is targeted against the spike protein of the virus -- the part it uses to attach to the cells it infects.
This Phase 2 trial involving about 450 volunteers with coronavirus infections showed nearly everyone had cleared the virus by 11 days – including people given placebo. The highest dose of antibody sped up the process of clearing the virus, Lilly said in a statement. No one needed help breathing using a ventilator, and no one who got placebo or treatment died.
There was a 72% reduction in hospitalization rates among those treated, but only a very few people were hospitalized. Lilly said 1.7% of the patients who got the antibody were hospitalized, compared to 6% of those on placebo. But in terms of numbers, this meant five people out of 302 treated with the antibody were sick enough to need hospitalization, compared to nine people out of 150 given placebos.
“Most study hospitalizations occurred in patients with underlying risk factors (age or BMI), suggesting a more pronounced treatment effect for patients in these higher-risk groups,” Lilly said.
“LY-CoV555 was well-tolerated, with no drug-related serious adverse events reported,” it added.
“These interim data from the BLAZE-1 trial suggest that LY-CoV555, an antibody specifically directed against SARS-CoV-2, has a direct antiviral effect and may reduce COVID-related hospitalizations,” said Dr. Daniel Skovronsky, Lilly's chief scientific officer and president of Lilly Research Laboratories.
“The results reinforce our conviction that neutralizing antibodies can help in the fight against COVID-19.”
The company is recruiting volunteers to try a combination of this monoclonal antibody with another one that targets a different part of the virus.