US pharmaceutical firm Eli Lilly on Tuesday paused a late-stage trial of its experimental lab-produced antibody treatment against Covid-19 over an unspecified safety concern, the company said.
“Lilly is supportive of the decision by the independent DSMB (data safety monitoring board) to cautiously ensure the safety of the patients participating in this study,” a spokesperson told AFP in a statement.
The Phase 3 randomized control trial is a study of hospitalized Covid-19 patients that began in August across more than 50 sites in the United States, Denmark and Singapore with the aim of recruiting 10,000 people.
It is sponsored by the US National Institutes of Health.
Monoclonal antibody treatments have been making headlines recently after US President Donald Trump credited one therapy, developed by biotech firm Regeneron, with curing him of COVID-19.
Both Lilly and Regeneron last week applied to the US Food and Drug Administration for emergency use authorizations for their treatments.
It was not immediately clear whether the pause would affect other clinical trials that Lilly is running for COVID-19, for example among patients with mild to moderate forms of the disease or as a potential prophylaxis.
Monoclonal antibodies are a relatively new class of drugs that are best known for treating certain types of cancer and autoimmune disease.
Our own immune systems produce antibodies, which are infection-fighting molecules, and vaccines teach our bodies to be prepared to make the right ones for particular pathogens.
Another potential strategy is to give a patient fighting a disease the antibodies of someone who has already recovered. This is known as convalescent plasma, but it’s hard to procure plasma on a big enough scale to use it very widely.
The Covid-19 treatment which was being studied in the paused trial was based on an effective antibody Lilly found in a recovered patient that was then mass produced in a lab.
It is administered intravenously by drip.
Lilly didn’t disclose any detail about the safety concern or how many people are affected.
But generally speaking, mild side effects of IV administered therapies can include fevers, chills, and fatigue, while moderate to severe infusions can cause chest pain and shortness of breath.