Eli Lilly has reported positive proof-of-concept results from the BLAZE-1 clinical trial, which assessed SARS-CoV-2 neutralising antibody candidate LY-CoV555, to treat symptomatic Covid-19 in outpatients.
An interim analysis found that the drug candidate decreased rate of hospitalisation.
The study involved recently diagnosed patients with mild to moderate Covid-19 across placebo, 700mg, 2800mg and 7000mg arms.
According to the data, the prespecified primary endpoint of change from baseline in viral load at day 11 was reached at the 2800mg dose level, but not with the other doses.
Lilly added that majority of patients, including those on placebo, had near complete viral clearance by day 11.
Further analyses of viral data showed that LY-CoV555 improved viral clearance earlier at day 3 and decreased the proportion of participants having persistently high viral load at later time points.
Meanwhile, the prespecified endpoint of Covid-19-related hospitalisation or ER visit was demonstrated in 1.7% of patients on Lilly’s drug across dose groups, versus 6% on placebo. This is said to indicate a 72% risk reduction in this population.
Most hospitalisations were in patients who had underlying risk factors such as age or BMI. The company expects to confirm this finding in ongoing studies.
No progression to mechanical ventilation or death was reported across treatment arms.
Furthermore, exploratory analyses revealed a more rapid symptoms improvement in participants treated with LY-CoV555 compared to placebo.
LY-CoV555 was well-tolerated, without any drug-related serious adverse events. Treatment emergent adverse events were observed to be similar across all dose groups and comparable to placebo.
Eli Lilly chief scientific officer Daniel Skovronsky said: “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 hospitalisation.”
The BLAZE-1 trial is ongoing to evaluate LY-CoV555 in combination with LY-CoV016, a second Lilly antibody that binds a different epitope in the SARS-CoV-2 spike region.
Last month, Lilly launched the Phase III BLAZE-2 trial of LY-CoV555 to prevent Covid-19 in residents and staff at long-term care facilities.