Researchers shutter 2 Covid-19 studies as monitors flag Eli Lilly antibodies as a flop for pneumonia, hospitalized patients — but EUA hunt continues
Two weeks after the safety data monitoring group advised researchers to hit the hold button on a clinical trial of Eli Lilly’s antibody bamlanivimab (LYCoV55) for patients hospitalized with Covid-19, the trial overseers are back with fresh directions to shutter the study after losing faith that the drug could help this group of patients.
The monitors concluded, however, that there were no safety issues involved, which will likely encourage continued belief that Lilly can still nail down an emergency marketing application for less-sick patients.
On Tuesday morning, Lilly followed up with more bad news about their costly Covid-19 efforts, which hit their top-line numbers for Q3. A Phase II study for LY3127804, an experimental antibody targeting Angiopoietin 2, was dropped from the pipeline, without explanation. The move to yank the study was noted in their chart on the updated pipeline.
Researchers were studying the drug for pneumonia patients hospitalized with COVID-19 on the theory that inhibiting Ang2 would reduce the need for ventilation. In response to a query, a Lilly spokesperson told me the program was halted in September due to futility. There were no safety issues involved.
Lilly’s shares were down more than 5% Tuesday, ahead of the bell.
In a statement on the bamlanivimab move, Lilly noted:
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. In this updated dataset, differences in safety outcomes between the groups were not significant.
The original halt to the study — part of a master protocol effort dubbed ACTIV-3 run by the National Institute of Allergy and Infectious Diseases that combined the antibody with Gilead’s remdesivir — came about after one group in the study appeared to do better than another, though the company never identified which group.
Now, Lilly says that while the monotherapy added to other drugs doesn’t appear to help hospitalized patients, they say they “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.”
Data from that BLAZE-1 Phase II study are being used to back Lilly’s application for an emergency use authorization. And President Trump has already touted the drug as a veritable cure.
There are several ongoing studies, including BLAZE-1. The other 2:
— ACTIV-2, the NIH-sponsored study in recently diagnosed mild to moderate Covid-19 patients.
— BLAZE-2, Lilly’s Phase III study of bamlanivimab for the prevention of Covid-19 in residents and staff at long-term care facilities.
The trial data for the first round of drugs aimed at Covid-19 have offered a mixed batch of positive and negative results.
Gilead was the first to get an EUA for remdesivir, and the first to get full approval. But it also won the OK after a WHO study concluded that the drug did not improve mortality rates.
Lilly has had to contend with other setbacks as well, including reports that the manufacturing facility that makes its antibody was cited for serious quality control concerns. The antibody bamlanivimab was developed originally by AbCellera and then partnered with Lilly.
For a look at all Endpoints News coronavirus stories, check out our special news channel.