A drug designed to treat COVID-19 could be authorized for use as soon as September if testing goes well, the chief scientist at Eli Lilly and Co. said Wednesday. If approved, the treatment could be available in September, October or November, Daniel Skovronsky told Reuters. "If in August or September we're seeing the people who got treated are not progressing to hospitalization, that would be powerful data and could lead to emergency use authorization [from the FDA]," he said. The company is also starting preclinical studies of a third antibody treatment, which could enter clinical trials in coming weeks, he added. The two drugs in human trials are called monoclonal antibodies, which are created by using immune cells. The two treatments block the spike protein on the coronavirus that allows it to enter human cells. Monoclonal antibodies have been used to treat cancer, rheumatoid arthritis and other conditions, the news service reported, and they are more likely to be effective against COVID-19 than other drugs that are being repurposed from other uses. "It's good to have two antibodies. The downside is that manufacturing is precious. We have limited manufacturing capacity," he said. The goal is to have one antibody that people can use at the lowest dose possible, he said. If a single antibody drug is approved, the company could make hundreds of thousands of doses by the end of the year. If effective, these monoclonal antibodies could prevent COVID-19 and might be available before a vaccine, Skovronsky said. However, drug manufacturers likely won't be able to create the drug for everyone. The drugs would likely go to vulnerable groups, such as nursing home patients, where vaccines are less effective. "Global capacity for antibodies is just not high enough that we could ever think about adequate doses" for billions of people, he said. The company announced the start of a phase 1 study for its second COVID-19 antibody treatment on Monday and announced the start of a phase 1 study of its first antibody treatment on June 1, but it has not issued a formal statement about the timeline of the two drugs. Source
