Eli Lilly says other trials continuing after NIH study paused
Oct 17 2020
The recommendation to stop the trial came from the independent data safety monitoring board, which monitors the trials and cited safety concerns, according to the statement.
ACTIV-3, created to expand to test several monoclonal antibody treatments types, is one of four ongoing or planned trials in the National Institutes of Health's Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV) programme.
No details around the exact safety issues were provided.
He said "it's not at all unusual for unexpected illnesses that occur in large studies over their duration". However, only a small number of patients have been treated with LYCoV555 so far, which can result in ambiguity as the data may not be able to provide clarity.
Lilly's stock price slide about 0.5 percent in premarket trading Wednesday to $149.25 as of 7:15 a.m. A Lilly spokeswoman declined to comment further on why the trial was halted. But this latest pause to Johnson & Johnson's trial seems to support the stance of organizations such as The National Vaccine Advisory Committee (NVAC), which urged federal authorities to stick to the traditional approval process rather than rushing to get a vaccine out before it's efficacy and safety are properly evaluated.
Johnson & Johnson temporarily suspended clinical trials of the emerging corona virus vaccine after a mysterious disease emerged.
The final stage of J&J's trial had started recruiting participants in late September, with a goal of enrolling volunteers across more than 200 United States and global locations. Although clinical studies have resumed in many countries, the US study is under clinical hold.
Pharmaceutical companies have been under increasing pressure from the Trump Administration to produce a working Covid-19 vaccine, with CNN reporting that the president has taken to calling drug companies to check on vaccine progress.
The ACTIV-3 study is now the only study being conducted by Lilly on COVID-19 patients who have been hospitalized, according to the statement.
This was due to the antibody treatment demonstrating positive results in an interim analysis, showing that the drug helped to reduce hospitalisation and accident and emergency visits for COVID-19 patients. One is named LY-CoV555 and the other is LY-CoV016.
Lilly is testing the experimental antibody with Canadian company AbCellera.
Antibodies are powerful anti-infective treatments, but they are generally thought to work best at early stages of the disease. Regeneron has also submiited a request for EUA.
Should a treatment appear to be safe and effective in the initial stage after review by the DSMB, the treatment is to be advanced to stage 2 testing, where more volunteers are enrolled.