Antibody development for treating COVID-19 continues producing positive results, the latest being from Eli Lilly and Co.’s bamlanivimab (LY-CoV-555), which reduced nursing home residents’ risk of contracting symptomatic COVID-19 by 80%, according to new data from its phase III Blaze-2 study.
Antibodies continue to be the bridge between the patients and a vaccine rollout. Bamlanivimab has emergency use authorization from the FDA for treating mild to moderate COVID-19 in high-risk patients. Daniel Skovronsky, Lilly's chief scientific officer and president of Lilly Research Laboratories, said he wants to enlarge the company and the drug’s role. He added that he looks forward “to working with regulators to explore expanding the emergency use authorization to prevent the spread of COVID-19 in these facilities."
Once each participant reached the eight-week follow-up mark in the Lilly study, there was a significantly lower frequency of symptomatic COVID-19, which was the primary endpoint, in the bamlanivimab treatment arm vs. placebo (odds ratio 0.43, p=0.00021). For the prespecified subgroup of nursing home residents, there was also a significantly lower frequency of symptomatic COVID-19 in those treated with bamlanivimab vs. placebo (odds ratio 0.20; p=0.00026).
The results suggest residents randomized to bamlanivimab have up to an 80% lower risk of contracting COVID-19 vs. residents in the same facility who were randomized to placebo, the company said.
Results for all key secondary endpoints also reached statistical significance in both the overall and resident populations, who were randomized to receive either 4,200 mg of bamlanivimab or placebo.
Lilly is steps ahead of Regeneron Pharmaceuticals Inc.’s monoclonal antibodies casirivimab and imdevimab, which are in a phase III for treating hospitalized COVID-19 patients. Data released Jan. 4 showed treating seronegative patients with the cocktail lowered the risk of death or receiving mechanical ventilation. The cocktail also reduced the time-weighted average daily viral load through day seven by -0.54 log10 copies/mL and through day 11 by -0.63 log10 copies/mL (nominal p=0.002 for combined doses).
Tarrytown, N.Y.-based Regeneron has enrolled nearly 15,000 patients and, according to George Yancopoulos, Regeneron’s president and chief scientific officer, the company hopes to continue to “demonstrate the value of using our cocktail as a bridge treatment until the point that vaccines help the world hopefully achieve widespread immunity.”
Lilly’s new data are “a remarkable result,” wrote SVB Leerink analyst Geoffrey Porges on Jan. 21, adding that it “could be a game-changing addition to ongoing vaccine rollouts in the fight against COVID-19. However, this hinges on quick, targeted distribution of antibodies to high-risk individuals by the U.S. government, which is a significant unknown factor, and infused administration continues to post a challenge to distribution.”
In December, the U.S. government bought 650,000 additional doses of bamlanivimab for $812.5 million. Doses are to be delivered through Jan. 31. That brought the total doses purchased by the U.S. government to 950,000.
The U.S. NIH’s National Institute of Allergy and Infectious Diseases partnered with Lilly in the study, while Abcellera Biologics Inc. discovered the antibody and collaborated in its development.
The U.S. government cut a new agreement with Regeneron on Jan. 12 that brings an additional 1.25 million doses of the cocktail, bringing the total to more than 1.5 million doses. The government said it will buy all the finished doses of the casirivimab and imdevimab cocktail delivered by June 30.