- Eli Lilly on Monday became the first biopharmaceutical company to bring an engineered antibody drug against the coronavirus into human clinical testing.
- The antibody known as LY-CoV555, is being studied in a placebo-controlled Phase 1 trial in patients hospitalized with COVID-19, with results expected by the end of June. Lilly developed the antibody through a collaboration with the private biotech AbCellera.
- The news puts Lilly ahead of Regeneron, Vir Biotechnology, AstraZeneca and others who have announced efforts to develop antibodies against COVID-19. The medicines, if successful, could provide short-term protection for people exposed to the virus, or treatment for those who have been infected, which could help manage the outbreak until a safe and effective vaccine is available.
With news of the start of Eli Lilly's trial Monday, a new front began in the global battle against the coronavirus — the race to develop engineered antibodies.
These drugs, which are synthetic versions of the molecules our bodies produce to fight infections, aren't a panacea. Ultimately, it'll likely be a vaccine that finally ends the pandemic. But it's unclear if and when a safe and effective vaccine will be available, and how long it will take afterwards to achieve 'herd immunity' that protects the greater population.
Additionally, there are only two medicines that have been granted emergency use by the Food and Drug Administration against COVID-19. It's unclear if one, hydroxychloroquine, even helps COVID-19 patients. The other, remdesivir, has to be infused over five or 10 days and is only proven to shorten hospital stays for some patients.
Engineered antibodies, by contrast, could either help eradicate an existing infection, or provide short-term protection for someone who has been exposed to the virus. Their downside is that they're complex to manufacture and almost certainly have to be given in a clinic or hospital, limiting their reach. However, their effects kick in immediately, making them particularly helpful for the elderly, those with weak immune systems and healthcare workers — groups at high risk of not just infection, but serious health problems from COVID-19.
"We need something to bridge that gap" until a vaccine arrives, Andrew Adams, Eli Lilly's chief scientific officer of RNA therapeutics, told BioPharma Dive last month.
Lilly has brought the first of those drugs into human testing, leaping ahead of Regeneron, Vir, Amgen and others. Each of those companies is using different methods to screen for and design its antibodies. Lilly, for instance, engineered LY-CoV555 to mimic the effects of an antibody found in the blood sample of one of the first U.S. patients to recover from COVID-19.
As with vaccine makers, COVID-19 antibody developers are moving at unprecedented speed. Regeneron has said it plans to start its first trial this month. It took three months for Lilly scientists to design their drug and bring it to a placebo-controlled Phase 1 trial. Results from that study should be available later this month. If successful, that'll pave the way for "broader efficacy trials" in non-hospitalized COVID-19 patients, the company said in a statement.
Lilly also envisions studying the drug in a preventative setting, targeting vulnerable groups who aren't the best candidates for vaccines, like the elderly. And it has multiple other candidates on the way, including cocktails of multiple antibodies.
Lilly is preparing to manufacture its antibody globally, before it proves the drug works. The goal is to have "several hundred thousand doses available by the end of the year," chief scientific officer Dan Skovronsky said in the statement.