Lilly starts world first trial of an antibody drug for COVID-19

Less than three months after setting up a partnership with AbCellera seeking antibody drugs to treat coronavirus, Eli Lilly has started dosing patients with a lead candidate.

The two companies teamed up in March to find antibodies that could treat and prevent infection with SARS-CoV-2, the virus that causes COVID-19, with AbCellera providing the antibody discovery platform and Lilly contributing its development expertise.

The lead drug in the programme is LY-CoV555, a neutralising immunoglobulin G1 monoclonal antibody directed against the spike protein of SARS-CoV-2, which the virus uses to bind to human cells.

It is designed to block attachment, preventing the virus from entering cells and hijacking the cellular machinery to make copies of itself, and is based on an antibody found in the blood of a patient who had previously been infected with coronavirus but recovered.

Lilly says LY-CoV555 is the first drug to start human trials that has been specifically designed to treat the virus, rather than being repurposed for COVID-19 after first being developed for another disease.

Gilead’s remdesivir, for example, was originally tested as an Ebola vaccine, while others in trials are designed for diseases including malaria, HIV and influenza.

After receiving a blood sample from a recovered US COVID-19 patient, AbCellera screened more than five million immune cells to identify those that were involved in recovery from the disease, and from those found 500 fully human antibody sequences that it screened for activity against SARS-CoV-2.

LY-CoV555 had the most promising profile of those screened, but Lilly and AbCellera found a number of other antibodies that could serve as a back-up to the lead candidate, and may also be developed as part of a combination ‘cocktail’ against SARS-CoV-2.

In the first study, Lilly is comparing a single dose of the antibody to a matched  placebo in patients who have been hospitalised with COVID-19, aiming to assess the safety of the drug and provide an initial glimpse of antiviral activity.

The company thinks it should have preliminary data later this month and – assuming the drug is safe – will then move on to a larger phase 2 study that will include non-hospitalised patients.

Lilly says the drug could eventually start a multi-pronged development programme, with the treatment trials accompanies by studies of the antibody as a preventive measure in vulnerable people who are not good candidates for a vaccine.

At the same time it is ramping up manufacturing with the aim of having several hundred thousand doses available by the end of the year.

“If LY-CoV555 becomes part of the near-term solution for COVID-19, we want to be ready to deliver it to patients as quickly as possible,” said Daniel Skovronsky, Lilly's chief scientific officer.

Cases of coronavirus have now topped an estimated six million worldwide, claiming 371,000 lives.