Regeneron, Lilly Reveal Positive Results for Antibody Combos
(Bloomberg) -- Regeneron Pharmaceuticals Inc. and Eli Lilly and Co. each reported positive results from Covid-19 antibody drug combinations Tuesday, as both companies seek to expand use of their therapies and ensure effectiveness against new strains.
Regeneron said its antibody cocktail reduced Covid-19 cases by half and prevented all symptoms in people at high risk of catching the coronavirus. A combination of two antibodies that Lilly’s advancing to combat new variants cut the chances of hospitalizations and deaths by 70% in high-risk patients.
The two data sets “underscore the importance of antibody treatments,” Cantor Fitzgerald analyst Louise Chen wrote in a Tuesday note. “Virus mutations and slower-than-anticipated vaccine rollout could mean that Covid treatments will be needed for the foreseeable future.”
While antibody therapies have been a rare bright spot in treating people infected with the coronavirus, they’re expensive and production is hard to scale up. Logistical barriers to infusing contagious, recently-diagnosed patients have also hurt use of the treatments.
The Regeneron antibody cocktail could be used as a “passive vaccine” to protect those living with others who are already infected, the company said in a statement Tuesday, citing an early analysis of 409 people participating in a phase 3 trial. The stock fell as much as 1.1% as of 2:30 p.m. in New York.
The study is evaluating the ability of the Regen-Cov antibody cocktail consisting of casirivimab and imdevimab to provide immediate, short-term protection against the virus. It may offer certain advantages over vaccines that take several weeks to induce immunity, which is then longer-lasting.
In an interim analysis of 186 people who received the treatment, 10 became infected with Covid-19, but no one experienced symptoms. In the placebo group, 23 of 223 people tested positive, with eight showing symptoms and one death. Those treated with the therapy also had lower viral loads and shorter periods of infection, according to the study.
The trial, run jointly with the U.S. National Institute of Allergy and Infectious Diseases, enrolled more than 2,000 people. The company expects confirmatory results in the second quarter.
Lilly said on Tuesday that its combination of the antibodies bamlanivimab and etesevimab was effective in high-risk patients with a new Covid-19 diagnosis.
Bamlanivimab alone received emergency-use authorization from the U.S. Food and Drug Administration in November, and the regulator is currently reviewing the combination, Lilly said.
Lilly’s late-stage trial enrolled 1,035 patients. There were 11 Covid-related hospitalizations or deaths from any cause among patients taking the combination, and 36 among those on placebo. Patients who got the combination had a statistically-significant reduction in viral load and faster resolution of symptoms than those who got placebo, according to Lilly.
Lilly fell as much as 0.8% in New York.
Lilly will have shipped one million doses of bamlanivimab by the end of the month, executives said Tuesday on a conference call. The company is working to transition to the combination therapy over time, with the goal of offering broader protection in light of the coronavirus variants that have emerged globally.
More than 100,000 doses of the antibody drug combination are currently available, and Lilly is working with manufacturing partner Amgen Inc. to produce another million doses of the combination through the middle of the year, officials said. With limits to how much manufacturing can be expanded, Lilly is also studying lower doses, in hopes of stretching supply.
Final-stage trial results have convinced Lilly that the drug no longer requires placebo controls in scientific research, they said.
“We have a lot of data, we’ve shown part of the data that we’ve analyzed already, and now we can use these antibodies as control groups for future trials,” said Chief Scientific Officer Dan Skovronsky.
Lilly executives said they’re also looking to study coronavirus variants like one that surfaced in South Africa. The company is working to create next-generation antibody therapies in case it or other such variants become more widespread, they said.
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