Eli Lilly has begun dosing COVID-19 patients in a phase 1 trial of its AbCellera-partnered antibody. The initiation of the trial, which happened ahead of schedule, marks the start of a new phase of the response to SARS-CoV-2 in which study subjects will receive drugs designed specifically for the virus.
The first clinical trials of drugs to treat COVID-19 involved molecules that had already been tested in other indications. In parallel, researchers began racing to develop therapeutics against SARS-CoV-2 from the ground up and put them through preclinical assessments to support their use in humans. Lilly joined the race to create new drugs against the virus by partnering with AbCellera in mid-March.
At the time, AbCellera and Lilly set themselves the goal of getting an anti-SARS-CoV-2 antibody into the clinic within four months. Less than three months later, Lilly has disclosed the initiation of a trial of the AbCellera-partnered LY-CoV555, ahead of schedule and before other R&D groups.
Lilly is administering the antibody or placebo to hospitalized COVID-19 patients. In the phase 1, Lilly will primarily assess the safety and tolerability of the antibody with a view to running a larger study that will begin to validate its efficacy in vulnerable populations. Lilly expects to have data from the phase 1 trial by the end of June.
The delivery of safety and tolerability data could mark the start of a multifront R&D program. Lilly is planning to test its antibody in non-hospitalized COVID-19 patients and as a prophylactic in people who traditionally derive limited immunity from vaccines, such as seniors. To support the broad plans and potential commercial supply, Lilly is gearing up to produce “several hundred thousand doses” by the end of the year.
LY-CoV555 is perhaps the first drug specifically designed against SARS-CoV-2 to be tested in humans, but it is likely to be joined by a clutch of other assets soon. Regeneron is expected to start testing its COVID-19 antibody cocktail in humans this month, while drugs in development at AstraZeneca and through an alliance between GlaxoSmithKline and Vir Biotechnology could be in the clinic before the summer is over.
The antibodies may come to market before the first vaccines and, given the time frames involved in making and administering billions of prophylactics and the chance they may fail to induce immunity in all groups, could continue to play a key role in the response to COVID-19 even if trials underway at CanSino Biologics, Moderna and the University of Oxford are successful.
The trial will show if the positive effects shown by convalescent plasma transfusion are referred only to antibodies or also to other factors present in plasma and absent in antibodies concentrates.