Eli Lilly Pauses COVID-19 Antibody Phase III Trial Over Safety Concerns

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US pharma company Eli Lilly pauses the COVID-19 vaccine Phase III trial over safety concerns.

In the span of 24 hours, two late-stage COVID-19 medical trials have been paused over potential safety concerns, which is a major latest setback in the fight against the current pandemic.

Eli Lilly, a US pharmaceutical firm, suspended the Phase III trial of COVID 19 antibody treatment in hospitalized patients over an incident which is not yet specified.

Johnson & Johnson temporarily suspended its Phase III trial of the pandemic vaccine a day earlier to Eli Lilly’s vaccine trial suspension announcement due to an unspecified illness in a study patient.

Mathai Mammen, research head, J&J, told the investors on Tuesday that the halt is a “temporary pause” and might not be related to their drug.

AstraZeneca, a British firm, was first to announce a pause in its vaccine trials last month. The halt was announced after a patient in Britain was diagnosed with a spine inflammation condition. Later the trials resumed around the world but remained suspended in the US.

Eric Topol, the Scripps Research Institute, in a tweet remarked that the news about the safety concerns of Lilly’s antibody treatment is surprising to him as the earlier trial stages did not reveal any serious side effects. He hopes this pause will be brief, and he was expecting the details about it quickly and added that it is good to be cautious.

Treatment for Trump

A spokesperson from Lilly made a statement on Tuesday and, in the statement mentioned that Lilly is supportive of the decision made by the Data Safety Monitoring Board, DSMB, cautiously ensuring the safety of the participating patients.

The study was initiated in more than 50 sites across the United States, Denmark, and Singapore, with around 10,000 people participating in August.

A lab-produced antibody treatment by Regeneron, a biotech firm, has been making headlines lately after US President Donald Trump credited a therapy developed by the firm to have cured him of COVID-19. Lilly and Regeneron both applied for emergency use authorization for their treatments to the US Food and Drug Administration last week.

Monoclonal antibodies are a relatively new class of drugs, best known for cancer and autoimmune disease treatment.

The human immune system produces antibodies for particular pathogens, and the vaccines teach the body to be prepared and make specific antibodies in future invasions by the same virus.

The paused COVID-19 treatment was based on an effective antibody discovered by Lilly in a recovered patient.

The host immune cell produced antibodies can be cultured in a lab, and the desired proteins can be produced en masse.

The details of the safety concerns or the number of people affected are not disclosed by Lilly.

Generally speaking, therapies that are administered intravenously may show mild side effects like fever, chills, and fatigue, while moderate to severe infusions can result in chest pain and shortness of breath.

J&J seeks to reassure

Meanwhile, J&J moved to buoy confidence in their vaccine. Mathai Mammen, J&J, said in a conference call that in large studies, the occurrence of unexpected illnesses is not at all unusual. He added that in some cases, serious adverse events may or may not have something to do with the investigated drug or vaccine.

Globally, J&J is one of the 11 organizations to start a Phase III trial on the pandemic vaccine.

For the final stage of the J&J trial, participants were recruited in late September, with the aim of enrolling volunteers from 200 US and international centers.

Under Operation Warp Speed, Washington has given the multinational a funding that amounts to $1.45 billion.

The vaccine is a modified cold-causing adenovirus along with a part of the new coronavirus called the spike protein that is used to invade human cells. The single-dose vaccine is modified to eliminate its replication ability.

The same technology used by J&J in its Ebola vaccine received approval for marketing from the European Commission this July.

At the close of trading, Lilly was down 2.9%, and  J&J was down 2.3%.

Source

US pharma company Eli Lilly’s pauses COVID-19 vaccine Phase III trial over safety concerns.

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