Lilly's bamlanivimab prevents Covid-19 at nursing homes in BLAZE-2 trial
Jan 24 2021
The 965 Covid-19 negative subjects (299 residents and 666 staff) were included in the analysis of primary and key secondary endpoints for evaluating prevention, while 132 Covid-19-positive participants (41 residents and 91 staff) were part of the exploratory analyses for analysing treatment.
A total of 11 deaths of residents were reported, including deaths not related to Covid-19 in the placebo group versus five in bamlanivimab group.
Bamlanivimab, which is authorized for use in high-risk COVID-19 patients with mild to moderate disease, is a so-called monoclonal antibody - meaning it provides a manufactured version of antibodies the immune system naturally makes to fight an infection. There were no COVID-19 attributed deaths in the bamlanivimab arm.
In Eli Lilly's announcement, Skovronsky said that after the Food and Drug Administration previously provided an emergency use authorization for bamlanivimab, the company hopes to work "with regulators to explore expanding the emergency use authorization to prevent the spread of COVID-19 in these facilities". In the trial, the safety profile of bamlanivimab was consistent with observations from the Phase 1 and Phase 2 trials.
Lilly will seek an EUA for bamlanivimab in the prevention of COVID-19 in unvaccinated residents of nursing homes that are experiencing outbreaks of the disease, he said.
BLAZE-2 is a first-of-its-kind COVID-19 trial created to evaluate this vulnerable population by addressing the challenging aspects of running a clinical trial in long-term care facilities, which normally do not conduct clinical trials.
The single antibody treatment is administered as an infusion in a hospital or other health care setting.
While the BLAZE-2 trial is ongoing, full results from the study are due to presented at an undisclosed future medical congress and also submitted for publication in an unnamed peer-reviewed clinical journal.
The data show antibodies could be useful as a COVID prevention tool in vulnerable populations as an additional tool to vaccines, SVB Leerink analyst Geoffrey Porges said in a note Thursday.
Regeneron has REGN-2, a dual-drug antibody cocktail that also bears and FDA emergency use authorization. Patients and physicians can visit covid.infusioncenter.org.
The federal government bought hundreds of thousands of doses of bamlanivimab and a similar drug from Regeneron, which President Donald Trump received when he was sick with COVID-19 in October.
The catch? The data are limited to long-term care facilities, where vaccination is now underway-and despite their utility, antibody thereapies are having a tough time catching on. Serious adverse events were reported at a similar frequency in the bamlanivimab and placebo groups.