Eli Lilly antibody treatment fails COVID-19 study
pharmafile | October 27, 2020 | News story | Manufacturing and Production |
The US Government is putting an early end to clinical trials testing Eli Lilly’s antibody drug in COVID-19 patients.
The trial tested bamlanivimab in patients hospitalised with the virus and is being administered in combination with remdesivir. On 13 October, Eli Lilly paused the trial due to potential safety concerns.
On Monday, the National Institutes of Health found that the treatment did not pose any significant safety risks for patients, but the antibody drug was found to have no benefit in helping those hospitalised with COVID-19 to recover. For this reason, the trial was halted. However, officials at the company believe Lilly will continue to carry out studies into how the antibody treatment can prevent the progression of coronavirus.
In a statement posted to its website, Eli Lilly said: “All other studies of bamlanivimab remain ongoing, including 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 COVID-19 in the ambulatory (non-hospitalised) setting, studying bamlanivimab as monotherapy and in combination with etesevimab; and BLAZE-2, Lilly’s Phase 3 study of bamlanivimab for the prevention (prophylaxis) of COVID-19 in residents and staff at long-term care facilities.
“Based on data from BLAZE-1, Lilly submitted a request for EUA for bamlanivimab for the treatment of recently diagnosed mild to moderate COVID-19 illness in high-risk patients to the U.S. FDA in early October. While there was insufficient evidence that bamlanivimab improved clinical outcomes when added to other treatments in hospitalised 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.”
Chris Christie, the former Governor of New Jersey, said that he had received the antibody treatment when he was hospitalised with coronavirus earlier this month, after he attended a 26 September event hosted at the White House, where Donald and Melania Trump also contracted the virus.