A lab-made antibody treatment has shown encouraging results in preventing Covid-19 in hospitals, at least in some preliminary data. On Tuesday, pharmaceutical company Eli Lilly announced that its experimental antibody treatment was lowering the rate of hospital admissions for outpatients with Covid-19 compared to a placebo control group. But the results are not yet a clear home run.
Eli Lilly’s treatment, called LY-CoV555, is a monoclonal antibody. Monoclonal antibodies are antibodies made from a single cell and cloned in the laboratory. Although they are based on naturally produced antibodies from the immune system, they are often optimized to be more effective or safer in whatever task they are supposed to do. Monoclonal antibodies are used in medicine to treat conditions like cancer, autoimmune diseases, and viral infections, and scientists have been very confident of using them to treat the infection that causes Covid-19.
LY-CoV555 is derived from a type of neutralizing antibody – an antibody that prevents the coronavirus from infecting SARS-CoV-2 cells – found in Covid-19 survivors. It was originally discovered by scientists at biotech company AbCellera, which has since partnered with Eli Lilly to develop it. A phase III study for LY-CoV555 is already being carried out in cooperation with the National Institutes of Health.
These latest results come from an “interim analysis” of data from a Phase II study of LY-CoV555. The ongoing study, called BLAZE-1, is designed to test the safety and optimal dose of the treatment rather than its effectiveness. By the end, 800 participants are to be recruited, all of whom have been diagnosed with mild to moderate Covid-19, but who are not necessarily sick enough to require hospitalization or emergency care. The volunteers were randomized into one of four groups: one received a placebo and the other three received different doses of LY-CoV555.
Those who were given LY-CoV555 (across all dose groups) had to go to the hospital or the emergency room less often than those who received the placebo, the company said Tuesday. Straight 1.7% of LY-CoV555 patients required hospital care compared to 6% on placebo, representing a relative risk reduction of 72%. In addition, the treatment appeared to be well tolerated, no serious drug-related adverse event was reported, and there was little evidence that the virus had strong innate resistance to the antibody in patients.
“These preliminary data from the BLAZE-1 study suggest that LY-CoV555, an antibody specifically directed against SARS-CoV-2, has a direct antiviral effect and can reduce COVIDHospital stays “ Daniel Skovronsky, Eli Lilly’s chief scientist and president of Lilly Research Laboratories, said in one statement released by the company. “The results confirm our belief that neutralizing antibodies can help in the fight against COVID-19.”
Although the company has announced that it will present these Results in a peer-reviewed journal that are not yet available, so all results should be viewed with reasonable caution now. And during Overall, the results seem promising, with a few quirks that could question them.
For example, only in the group that received the median dose of LY-CoV555 (2,800 milligrams) was the primary objective of the study achieved, in which the treatment group had significantly lower virus levels in their system than the placebo group; No similar result was found for the low- or high-Dose group. This is not necessarily harmful, but many drugs tend to have a dose-response curve where the higher the dose, the greater the effects on the body.
It is possible that this study was simply not designed to measure the true strength of the treatment – preventing the virus from growing as if nothing were done. In fact, the company argues that its early analysis shows that people given LY-CoV555 had fewer viruses in their system on day three than the placebo group. Most of the people in the study, whether placebo or not, had cleared the infection by day 11. It is possible that additional benefit from treatment would have been demonstrable in patients who have been sick for a long time.
It is also possible that the positive results, including the lower hospitalization rate, are a statistical accident. Even if that is the case In this case, it does not rule out that monoclonal antibodies could be a useful treatment, especially in more severe cases. It just means that all early results, however good they may be, must be carefully examined and replicated by others before we can be certain of them.