An NIH-sponsored phase III trial testing Eli Lilly and Co.'s SARS-CoV-2 neutralizing antibody candidate, LY-CoV555, alongside the Gilead Sciences Inc. antiviral Veklury (remdesivir) has been paused at the request of its data safety monitoring board, the company told BioWorld.
The reasoning behind the move wasn't immediately clear, but it was the third such high-profile development following a vaccine trial pause announced by Johnson & Johnson on Oct. 12 and another hold still affecting a trial of Astrazeneca plc's lead COVID-19 vaccine in the U.S.
"Safety is of the utmost importance to Lilly," a statement from Lilly said on Oct. 13. "We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment."
Lilly announced on Oct. 7 that it had requested an emergency use authorization for the candidate, the first products of its ongoing collaboration with Abcellera Biologics Inc. It wasn't clear what effect the pause might have on that request or whether other studies evaluating LY-CoV555, such as Lilly's Blaze-1 study on its own and in combination with another antibody, might also be paused.
The paused NIH trial, ACTIV-3, is one of four organized by the National Institute of Allergy and Infectious Diseases as part of its Accelerating COVID-19 Therapeutic Interventions and Vaccines public-private partnership program. Its adaptive two-stage design can be modified to test additional experimental therapies.
The initial stage of the ACTIV-3 trial, as announced on Aug. 4, aimed to enroll about 300 volunteers who have been hospitalized with mild to moderate COVID-19 with fewer than 13 days of symptoms, according to the NIH. The trial's design then calls for participants to be randomly assigned to receive either an I.V. infusion of LY-CoV555 or a saline placebo infusion. Participants are also receiving standard care for COVID-19, including remdesivir, the NIH said.
"Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study," the company said.
The NIH did not immediately respond to an inquiry about the state of the study.