After Johnson & Johnson, Eli Lilly pauses clinical trial of coronavirus antibody treatment over safety concerns
Drugmaker Eli Lilly has halted a US-government-sponsored clinical trial of its Covid-19 antibody treatment because of a potential safety concern, the company said. It is unclear exactly what safety issues prompted the pause. The experimental treatment, called LY-CoV555, is similar to the Regeneron’s antibody treatment that was given to President Donald Trump after he was diagnosed with coronavirus. The pause in the Lilly trial comes a day after Johnson & Johnson paused its Covid-19 vaccine trial after a volunteer had an unexplained illness.
“Out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment. Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study,” said Lilly spokeswoman Molly McCully in an emailed statement to Reuters.
The paused trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The LY-CoV555 antibody was discovered by Abcellera Biologics (Vancouver, British Columbia) in collaboration with NIAID’s Vaccine Research Center. Subsequently, it was developed and manufactured by Lilly Research Laboratories, Eli Lilly and Company (Indianapolis, Indiana), in partnership with AbCellera. When the phase 3 trial was announced in August, Lilly had planned to enroll about 300 volunteers who have been hospitalized with mild to moderate Covid-19 with fewer than 13 days of symptoms.
An NIH spokeswoman said the trial, which had enrolled 326 Covid-19 patients, was paused when the independent safety board found that after five days of treatment, “the group of patients who had received the antibodies showed a different “clinical status” than the group who had received a saline placebo, a difference that crossed a predetermined threshold for safety (meaning that there was an overall difference between the two patient groups),” reports the New York Times. The statement did not mention the nature of the participants’ conditions. The investigators will continue to follow the patients alraedy enroled, and the safety board is expected to review the data again on October 26.
Dr Eric Topol, founder, and director of the Scripps Research Translational Institute, tweeted: “Surprising that Lilly’s monoclonal antibody has a safety concern to pause trials, as the safety issue has not manifest in their program or Regeneron's previously. Hopefully, a brief pause and we'll get details quickly. Good to be cautious.”
Surprising that Lilly's monoclonal antibody has a safety concern to pause trials, as the safety issue has not manifest in their program or Regeneron's previously. Hopefully a brief pause and we'll get details quickly. Good to be cautious.https://t.co/ZaMQdidkkA— Eric Topol (@EricTopol) October 13, 2020
The Eli Lilly trial was designed to test the benefits of the antibody on hospitalized Covid-19 patients, compared with a placebo. Interim trial data in September had shown that the experimental antibody treatment reduced the need for hospitalization and emergency room visits for patients with moderate Covid-19. According to the company, the rate of hospitalizations and ER visits was 1.7% (5 out of 302) for LY-CoV555 versus 6% (9 out of 150) for placebo -- a 72% risk reduction in the limited population. “LY-CoV555 was well-tolerated, with no drug-related serious adverse events reported. Treatment-emergent adverse events were similar across all dose groups and comparable to placebo. Viral RNA sequencing revealed putative LY-CoV555-resistance variants in the placebo and all treatment arms. The rate of resistance variants was numerically higher in treated patients (8%) versus placebo (6%),” announced the company in a statement on September 16.
Recently, Lilly also said that it has submitted a request for emergency use authorization (EUA) to the US Food and Drug Administration (FDA) for LY-CoV555. “Based on the combination therapy data, along with the previously disclosed findings for LY-CoV555 monotherapy, Lilly has engaged global regulators, including the FDA regarding potential EUA. Lilly has now submitted an initial request for EUA for LY-CoV555 monotherapy in higher-risk patients who have been recently diagnosed with mild-to-moderate Covid-19,” said the company on October 7.