Why did Eli Lilly stop antibody trial on hospitalized Covid-19 patients? Studies on milder cases to continue
The company said that other studies involving experimental treatment in people who have milder cases of coronavirus or who have been exposed to the virus will continue
Drugmaker Eli Lilly has confirmed that its antibody treatment bamlanivimab (LY-CoV555) does not improve recovery times for patients hospitalized with advanced coronavirus. Accordingly, a US government-sponsored clinical trial will no longer administer the drug to new patients hospitalized with Covid-19, implying that the hospital study has been stopped as it showed no benefits. The ACTIV-3 trial is an independent, National Institutes of Health (NIH)-sponsored study in hospitalized patients that was testing bamlanivimab in combination with remdesivir.
“The ACTIV-3 clinical trial is being run by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and is the only study evaluating the efficacy of bamlanivimab in hospitalized Covid-19 patients. Based on an updated dataset from the trial reviewed on October 26, no additional Covid-19 patients in this hospitalized setting will receive bamlanivimab. This recommendation was based on trial data suggesting that bamlanivimab is unlikely to help hospitalized Covid-19 patients recover from this advanced stage of their disease,” said the company in a statement.
The move is a setback for a promising treatment approach for Covid-19. President Donald Trump received a similar experimental treatment -- an antibody cocktail made by Regeneron on an emergency basis after he was diagnosed with Covid-19.
Previously, Eli Lily had paused the clinical trial of its Covid-19 antibody treatment because of a potential safety concern. Back then, an NIH spokeswoman had said the trial was paused when an 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. This implies that there was an overall difference between the two patient groups. “In this updated dataset, differences in safety outcomes between the groups were not significant,” explained Eli Lily in its latest statement.
The company said that other studies involving the antibody treatment in people who have milder cases of the disease or who have been exposed to the virus, would continue and that it remained optimistic that the treatment could work if given early in the course of the disease.
The remaining ongoing studies of bamlanivimab include ACTIV-2, the NIH-sponsored study in recently diagnosed mild to moderate Covid-19 patients, BLAZE-1, Lilly’s ongoing phase 2 trial in people recently diagnosed with coronavirus in non-hospitalized setting, and Lilly’s phase 3 study of bamlanivimab for the prevention of the disease in residents and staff at long-term care facilities.
“Based on data from BLAZE-1, Lilly submitted a request for EUA (emergency use authorization) for bamlanivimab for the treatment of recently diagnosed mild to moderate Covid-19 illness in high-risk patients to the US Food and Drug AdministratDA in early October. While there was insufficient evidence that bamlanivimab improved clinical outcomes when added to other treatments in hospitalized patients with Covid-19, we remain confident based on data from Lilly’s BLAZE-1 study that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of Covid-19,” said the drugmaker.