Viral loads in treatment group were consistent with previously disclosed data from the BLAZE-1 trial.
In results from a recent Phase-3 prevention trial, the neutralizing antibody bamlanivimab was shown to significantly reduce the risk of contracting symptomatic coronavirus disease 2019 (COVID-19) among the staff and residents of long-term care facilities. The trial was conducted by Eli Lilly and Company, in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the COVID-19 Prevention Network (CoVPN).
The trial included 1,097 participants who either worked or were residents at skilled nursing and assisted living facilities. The participants were randomly assigned to receive either 4,200 mg of the therapy or a placebo. 965 of the group tested negative for the SARS-CoV-2 virus and were included in the analysis of primary and key secondary endpoints that assessed for prevention, while 132 of them who tested positive were included in exploratory analyses for assessing treatment.
Findings from the trial showed that after 8 weeks of follow-up, a significantly lower frequency of symptomatic COVID-19 was seen in the treatment arm in comparison to the placebo arm. All key secondary endpoints also showed statistical significance in the overall trial population. Additionally, there were no deaths attributed to COVID-19 in the treatment arm, with 4 deaths occurring in the placebo arm.
"We are exceptionally pleased with these positive results, which showed bamlanivimab was able to help prevent COVID-19, substantially reducing symptomatic disease among nursing home residents, some of the most vulnerable members of our society," Daniel Skovronsky, Lilly's chief scientific officer and president of Lilly Research Laboratories said. "These data provide important additional clinical evidence regarding the use of bamlanivimab to fight COVID-19 and strengthen our conviction that monoclonal antibodies such as bamlanivimab can play a critical role in turning the tide of this pandemic.”
Over seen by an independent data and safety monitoring board, the BLAZE-2 trial saw that the safety profile of bamlanivimab was consistent with the other phases of the trial, with adverse events being reported at a similar frequency. Across various clinical trials, more than 4,000 patients have been treated with the therapy.
"The results of this innovative study further support the belief that bamlanivimab – and potentially other monoclonal antibodies – can reduce symptoms and may even prevent COVID-19," Myron S. Cohen, co-principal investigator and director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill said. "The antiviral activity seen with bamlanivimab treatment emphasizes the importance of early intervention to help counter the devasting impact the virus has had in this vulnerable population and other high-risk patients."