Pause clinical trial of The experimental antibody therapy of Eli Lilly & Co. will not resume once federal researchers have concluded that the drug is unlikely to help hospitalized patients with Covid-1
However, researchers from the National Institutes of Health, who initially stopped the study due to safety concerns, did not find that the treatment had caused any harm, which could prejudge a regulatory review of antibody use in a different setting.
Although the decision to discontinue the NIH-sponsored study means that Lilly’s treatment with antibodies may not work for the most extreme cases, other studies are underway to determine if it helps patients earlier in the disease. Of note, the finding that there is no safety issue in the hospital trial could remove a potential hurdle to the emergency solution that Lily is seeking to use the antibodies in patients outside the hospital.
On October 13, an independent data safety monitoring board for the so-called ACTIV-3 study, sponsored by the National Institute of Allergy and Infectious Diseases, part of the NIH, recommended that the study be stopped due to safety concerns. Since then, the board has found no difference in safety risks between the groups of patients receiving the antibody known as LY-CoV555 and those who did not.
This means that it is no longer possible for a hospital study to detect an unexpected safety problem that will spread to non-hospitalized patients where the antibody has shown promising results.
Antibody therapies are being developed by a handful of companies, including Regeneron Pharmaceuticals Inc., AstraZeneca Plc, GlaxoSmithKline Plc and its partner Vir Biotechnology Inc., and are seen as a bridge to the coronavirus vaccine. The drug class came to the forefront when President Donald Trump received experimental therapy with Regeneron antibodies to treat his Covid-19 attack. Regeneron also appealed to U.S. regulators earlier this month for permission for emergency use.
ACTIV-3 tests high-dose version of antibody treatment Lily develops with Canadian biotechnology AbCellera Biologics Inc. in combination with the antiviral drug remdezivir, but there are no indications that it is effective, leading an independent committee to recommend discontinuation. The study registered a total of 326 participants who were hospitalized with Covid-19.
In contrast to the results of a hospital trial sponsored by the company, a study of patients with milder cases of Covid-19 taking lower doses of LY-CoV555 yielded promising early results in September. This has become the basis of the US regulatory approach for emergency authorization for those considered “high-risk” with mild to moderate Covid-19.
The report is an indication that monoclonal antibodies can only work if given early in the course of a coronavirus infection, before the virus has a chance to penetrate deep into the lungs and cause serious damage.
Clinical trials of experimental antibody therapy in the outpatient setting, as well as preventive treatment in nursing homes, remain unaffected. The Independent Data Safety Monitoring Council, which oversees ACTIV-3, does not recommend any changes to another government-run trial known as ACTIV-2.
The Indianapolis-based drug giant said in a statement Monday that it remained confident that LY-CoV555 could prevent the disease from progressing. Lilly executives are expected to give an update to their experimental antibody program on Tuesday morning, as the company reports revenue for the third quarter.
Lily is currently in talks with Operation Warp Speed for delivery, CEO David Rix told Bloomberg earlier this month.
“With the help of Robert Langret.”
(Updates from the beginning of the second paragraph)