The phase 3 trial was sponsored by the United States National Institutes of Health (representation)
Washington:
U.S. pharmaceutical company Eli Lilly on Tuesday suspended an advanced trial of its laboratory-produced experimental antibody treatment against Covid-19 for an unspecified safety concern, the company said.
“Lilly supports the decision of the independent Data Safety Monitoring Board (DSMB) to prudently ensure the safety of patients participating in this study,” a spokesperson told AFP in a statement.
The Phase 3 randomized controlled trial is an inpatient study of Covid-19 that began in August at more than 50 sites in the United States, Denmark and Singapore with the goal of recruiting 10,000 people.
It is sponsored by the United States National Institutes of Health.
Monoclonal antibody treatments recently made headlines after US President Donald Trump credited a therapy, developed by biotech company Regeneron, for curing him of Covid-19.
Last week, Lilly and Regeneron applied to the US Food and Drug Administration for emergency use authorizations for their treatments.
It was not immediately clear whether the break would affect other clinical trials Lilly is conducting for Covid-19, for example in 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 diseases.
Our own immune systems produce antibodies, which are anti-infective molecules, and vaccines train our bodies to be prepared to make the right ones for particular pathogens.
Another potential strategy is to give a disease-fighting patient the antibodies of someone who has already recovered. This is called convalescent plasma, but it is difficult to obtain plasma on a scale large enough to use it very widely.
The Covid-19 treatment that was being investigated in the suspended trial was based on an effective antibody that Lilly found in a cured patient which was then mass produced in a lab.
It is administered intravenously by drip.
Lilly did not disclose any details about the security issue or the number of people affected.
But generally speaking, mild side effects from intravenous therapies can include fevers, chills, and fatigue, while moderate to severe infusions can cause chest pain and shortness of breath.
(Except for the title, this story was not edited by GalacticGaming staff and is posted from a syndicated feed.)
