Lilly’s Coronavirus Antibody Treatment Hits Pause Button Over Potential Safety Issues

By Sangeeta Chakraborty, Ph.D.

Indianapolis-based Eli Lilly’s leading antibody treatment for coronavirus, currently in three major clinical trials, recently came under the scrutiny of government health officials who asked the company to stop enrolling volunteers to one of their ongoing clinical trials—ACTIV-3—over “potential safety concerns.” At this time, details of the safety concerns are still under wraps because the trial data has only been reviewed by an independent panel of experts, while the company and the investigators have not been revealed.

However, “Lilly is supportive of the decision by the independent DSMB [data safety and monitoring board—a group of independent experts overseeing the trial] to cautiously ensure the safety of the patients participating in this study,” Eli Lilly spokeswoman Molly McCully said.

Bamlanivimab

Lilly’s antibody treatment to fight COVID-19 began in June after the company, along with AbCellera and NIAID’s Vaccine Research Center, spent three months developing a monoclonal antibody after identifying it from a recovered COVID-19 patient. The investigational antibody—Ly-COV555 (Bamlanivimab)—was later launched through the NIAID funded trial—ACTIV-3—that aimed to recruit approximately 300 volunteers who have been hospitalized with mild to moderate COVID-19.

Participants were randomly assigned to receive either an IV infusion of LY-CoV555 or a placebo. In addition to receiving Lilly’s Ly-COV555 antibody or a placebo, the patients in the trial were also administered Gilead Sciences antiviral drug remdesivir, a standard of care for COVID-19. “Monoclonal antibodies may provide short-term protection from SARS-CoV-2 and could serve as important components of the COVID-19 pandemic response until vaccines become available,” noted NIH in their news release.

Safety Issues

The news of the pause came last Tuesday after experts from DSMB found that after five days of treatment, the study had reached a “predefined threshold for safety,” where one of the two groups—antibody recipients vs. the placebo recipients—fared better than the other.

However, the board did not say which group—the treatment group or the placebo group—raised the safety concern that prompted the pause. Considering the trial results, the DSMB recommended the study investigators to stop enrollment to the trial “out of an abundance of caution.” However, data collection and follow-up of current participants for safety and efficacy of Ly-COV555 will continue as usual until the review board meets with the investigators again on Oct 26, the NIH said in a statement.

Coincidently, the pause in Lilly’s trial comes a day after Johnson & Johnson had their late-stage COVID-19 vaccine trial paused after a patient volunteer developed an unexplained illness. The results from J&J’s vaccine trial—ENSEMBLE—are also being reviewed and evaluated by the DSMB. Still, again, it is not known, at this time, whether the volunteer who got sick had received the actual vaccine or a placebo.

Last week, the company requested an emergency use authorization (EUA) from the Food and Drug Administration for its monoclonal antibody-based on results from another trial—BLAZE-1—that tested it in COVID-19 patients with mild to moderate symptoms. An interim analysis of BLAZE-1 showed promising results of Ly-COV555, combined with another Lilly antibody Ly-COV016 in reducing viral load, symptoms, and hospitalizations due to COVID-19.

Regeneron Pharmaceuticals Inc. and others are also testing similar antibody cocktails for COVID-19, and much to their delight, their efforts are being promoted by President Trump now that he recovered from COVID-19 after receiving Regeneron’s antibody as part of his treatment regimen. Trump has claimed his treatment was a “cure,” and has supported the authorization for widespread use of Regeneron and Eli Lilly’s drugs for covid-19.

Related Article: COVID-19: Eli Lilly Claims Efficacy, Seeks Speedy Emergency Use Authorization for Antibody Therapy

References

1. https://www.reuters.com/article/us-health-coronavirus-eli-lilly/eli-lilly-pauses-trial-of-antibody-drug-trump-touted-as-covid-19-cure-over-safety-concern-idUSKBN26Y2TE
2. https://www.lilly.com/news/stories/statement-activ3-clinical-trial-covid19-niaid-decision-pause-enrollment

Author

Sangeeta Chakraborty