US pharmaceutical firm Eli Lilly suspended its phase 3 trial of its treatment with laboratory-produced antibodies in hospitalized patients for an unspecified incident on Tuesday.
A day earlier, US pharmaceutical giant Johnson & Johnson temporarily halted its Phase 3 Covid-19 vaccine trial due to an unexplained illness in a study participant.
J&J head of research Mathai Mammen told investors on Tuesday it was a “temporary hiatus” that might not be related to his drug.
It is not unusual for end-stage clinical trials to find a problem; in fact, they are designed to increase the number of participants to thousands or tens of thousands to detect side effects that can be very rare.
Last month, British firm AstraZeneca became the first in the world to announce a pause in its vaccine trials after a patient in Britain was diagnosed with an inflammatory condition affecting the spine.
The trial was later resumed around the world, but remains suspended in the US for reasons that are unclear.
Physician and scientist Eric Topol, who heads the Scripps Research Institute, tweeted that he was surprised to hear about the safety concerns with Lilly’s antibody treatment, because the previous stages did not reveal any serious side effects.
“Hopefully a short pause and we’ll get the details quickly. It’s good to be cautious,” he said.
“Lilly supports the decision of the independent DSMB (data safety monitoring board) to cautiously ensure the safety of patients participating in this study,” a spokesman told AFP in a statement Tuesday.
The study began in August at more than 50 sites in the United States, Denmark and Singapore with the goal of recruiting 10,000 people.
Lab-produced antibody treatments have been making headlines recently after US President Donald Trump credited a therapy, developed by biotech firm Regeneron, for curing him from Covid-19.
Both Lilly and Regeneron last week applied to the US Food and Drug Administration for emergency use authorizations for their treatments.
Monoclonal antibodies are a relatively new class of drugs that are best known for treating certain types of cancer and autoimmune diseases.
The human immune system produces antibodies, which are infection-fighting proteins, and vaccines teach our bodies to be prepared to produce those suitable for particular pathogens.
The Covid-19 treatment studied in the paused trial was based on an effective antibody that Lilly found in a recovered patient.
The host immune cells that produce the antibodies can be grown in a laboratory to produce the desired proteins in bulk.
Lilly did not reveal any details about the security issue or how many people are affected.
But generally speaking, mild side effects of intravenous therapies can include fever, chills, and fatigue, while moderate to severe infusions can cause chest pain and shortness of breath.
Meanwhile, J&J moved to boost confidence in its vaccine.
“It is not at all unusual for unexpected illnesses (to occur) in large studies during their duration,” Mammen said in a conference call.
“In some cases, serious adverse events … may have something or nothing to do with the drug or vaccine under investigation,” he said.
The final stage of the J&J trial had begun recruiting participants in late September, with the goal of enrolling volunteers at more than 200 US and international locations.
J&J is one of 11 organizations globally that began a phase 3 trial with a Covid-19 vaccine.
Washington has given the multinational around $ 1.45 billion in funding under Operation Warp Speed.
The vaccine is based on a single dose of a cold-causing adenovirus, modified so that it can no longer replicate, combined with a part of the new coronavirus called spike protein that it uses to invade human cells.
J&J used the same technology in its Ebola vaccine, which received marketing approval from the European Commission in July.
At close of business, J&J was down 2.3 percent, while Lilly was down 2.9 percent.
.
