Raising hope of Covid-19 treatment at an early stage, an antibody therapy has been found to quickly reduce SARS-CoV-2 viral load in newly infected patients and cut hospitalization risk, US-based pharmaceutical company Eli Lilly said while revealing interim results of a clinical trial.
The Phase 2 study of the BLAZE-1 clinical trial evaluated LY-CoV555, a SARS-CoV-2 neutralizing antibody, for the treatment of symptomatic Covid-19 in the outpatient setting, the company said on Wednesday.
The trial enrolled mild-to-moderate recently diagnosed Covid-19 patients across four groups –placebo, 700 mg, 2800 mg, and 7000 mg.
Analyses of viral data demonstrated that LY-CoV555 improved viral clearance at an earlier time point — day 3 — and reduced the proportion of patients with persistently high viral load at later time points.
Most study hospitalizations occurred in patients with underlying risk factors — age or body mass index (BMI) — suggesting a more pronounced treatment effect for patients in these higher-risk groups.
Ongoing studies will seek to confirm this finding, the drugmaker said.
Across all treatment groups, including placebo, no patients progressed to mechanical ventilation or died, the results showed.
Exploratory analyses indicated a more rapid improvement in symptoms for patients treated with LY-CoV555 versus placebo, supporting the hospitalization effect.
The treatment was well-tolerated, with no drug-related serious adverse events reported.
“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,” Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories, said in a statement.
“The results reinforce our conviction that neutralizing antibodies can help in the fight against Covid-19.”
The company said it intends to quickly publish the results of this interim analysis in a peer-reviewed journal and discuss appropriate next steps with global regulators.
If proved to be effective in further analyses, this could be the first potential treatment for Covid-19 patients with a mild and moderate level of severity.
This is because the drug redeliver and the steroid dexamethasone has been found to be helpful in the treatment of patients with serious illness.
The BLAZE-1 clinical trial remains ongoing, testing LY-CoV555 in combination with a second Lilly antibody, LY-CoV016, which binds a different epitope in the SARS-CoV-2 spike region.A
The trial is currently enrolling a larger, confirmatory cohort of higher-risk patients, testing the ability of the antibody combination to reduce the number of patients with persistently high viral load and reduce COVID-related hospitalizations.
