A phase 3 trial of Eli Lilly’s investigational monoclonal antibody LY-CoV555 for the treatment of COVID-19 has been temporarily suspended out of an “abundance of caution” because of a “potential safety concern,” according to emails that government officials sent on Tuesday to researchers at testing sites. Lilly spokeswoman Molly McCully confirmed the news, which sent company shares down almost as much as 4%, saying “safety is of the utmost importance to [us],” and that the drugmaker “is supportive of the decision by the independent [data safety monitoring board] to cautiously ensure the safety of the patients participating in this study.”
No other details about the potential safety issue were disclosed. The adaptive ACTIV-3 trial was launched in August and in the process of enrolling participants. It is one of four studies led by the US National Institutes of Health (NIH) that are part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. The initial stage of ACTIV-3 was looking to recruit 300 volunteers who have been hospitalized with mild-to-moderate COVID-19. Participants are randomly assigned either an intravenous infusion of LY-CoV555 or placebo, and will also receive standard care for COVID-19, including Gilead Sciences’ Veklury (remdesivir).
After five days, patient symptoms will be assessed, as will their need for supplemental oxygen, mechanical ventilation or other supportive care. When it launched the trial back in August, the NIH noted that data collected on the fifth day would determine whether the investigational therapeutic will be administered to a larger group, adding that if LY-CoV555 turns out to be safe and effective, ACTIV-3 will seek to include another 700 participants. It will also begin enrolling more severely ill patients, such as those with organ failure requiring mechanical support, or COVID-19-associated dysfunction of organs other than the lungs. The primary endpoint is sustained recovery for 14 days after patients are released from hospital.
Follows J&J COVID-19 vaccine study halt
The news comes shortly after Johnson & Johnson announced that it had paused dosing in all clinical studies of its COVID-19 vaccine candidate JNJ-78436735, including the phase 3 ENSEMBLE trial, due to an “unexplained illness” in a participant. Prior to that, a late-stage trial of AstraZeneca’s experimental COVID-19 vaccine AZD1222 was put on hold due to a possible case of transverse myelitis in one subject, and while testing has resumed in some countries, it remains stalled in the US, where the FDA is conducting its review of the adverse event.
Last week, Lilly submitted a request to the FDA for emergency-use authorisation (EUA) of LY-CoV555 monotherapy for higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19. The neutralising IgG1 monoclonal antibody, also known as bamlanivimab, is being co-developed with AbCellera. Meanwhile, Regeneron Pharmaceuticals also recently filed an EUA request for its investigational dual antibody REGN-COV2 as a potential treatment for COVID-19.