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Eli Lilly says other COVID-19 antibody drug trials ongoing after study halted for safety concern

October 14, 2020

By Carl O’Donnell and Michael Erman

a large building: FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego

© Reuters/MIKE BLAKE
FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego

(Reuters) – Eli Lilly & Co on Wednesday said other trials of its experimental coronavirus antibody therapy remain on track after a government-run study testing the treatment in hospitalized COVID-19 patients was paused due to safety concerns.

Lilly said on Tuesday that an independent safety monitoring board requested a pause in the trial, called ACTIV-3, due to a potential safety issue.

The National Institutes of Health (NIH), which is collaborating with Lilly on the trial, said the advisory board paused the trial after seeing a “difference in clinical status” between patients on Lilly’s drug on those who received a placebo, without providing further detail.

Lilly on Wednesday said the paused trial is distinct from others it is conducting because it focuses on hospitalized patients who are

Eli Lilly antibody trial paused over safety concerns

October 14, 2020

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Checking in: The trial design calls for the data and safety monitoring board to examine results from the first 300 participants — including their need for supplemental oxygen, mechanical ventilation or other supportive care five days after receiving the treatment or a placebo — before proceeding with further enrollment.

The NIAID trial has so far enrolled 326 patients. An agency spokesperson said that the board overseeing the trial this morning “reached a predefined boundary for safety at day five.” The board will now decide whether the trial should add 700 more participants.

The NIAID spokesperson added that the pause in enrollment is “out of an abundance of caution” and the safety board is “continuing data collection and follow-up of current participants for safety and efficacy.”

The late-stage study is examining whether Lilly’s antibody, known as bamlanivimab, could help hospitalized patients. The treatment is a monoclonal antibody that mimics the antibodies

Eli Lilly pauses trial of antibody drug Trump touted as COVID-19 ‘cure’ over safety concern

October 14, 2020

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By Michael Erman and Carl O’Donnell

(Reuters) – Eli Lilly and Co said on Tuesday that the government-sponsored clinical trial of its COVID-19 antibody treatment similar to one taken by U.S. President Donald Trump has been paused because of a safety concern.

Trump touted the Lilly drug, along with the antibody treatment from Regeneron Pharmaceuticals Inc that he received for his COVID-19, as tantamount to a cure in a video he posted last week.

The announcement comes one day after Johnson & Johnson said it was forced to pause a large high-profile trial of its experimental coronavirus vaccine because a volunteer fell ill. J&J said it does not yet know if that person was given the vaccine or a placebo.

AstraZeneca Plc’s U.S. trial for its experimental COVID-19 vaccine has also been on hold for over a month after a volunteer in its UK study fell ill. Trials of that

Eli Lilly pauses trial of its monoclonal antibody to treat coronavirus

October 13, 2020

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Usually, clinical trials are paused because a volunteer has suffered a side effect or become ill, but the company did not say what happened.

“Safety is of the (utmost) importance to Lilly,” a spokesperson told CNN by email.

It said the trial’s Data Safety Monitoring Board (DSMB), an independent group of medical experts who monitor clinical trials, recommended the pause.

“The trial, evaluating Lilly’s investigational neutralizing antibody as a treatment for COVID-19 in hospitalized patients, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study,” the company said in the statement.

Lilly is testing a combination of two lab-engineered immune system proteins called monoclonal antibodies to treat severely ill patients with coronavirus. It is similar to the treatment

Are Antibody Infusions Safe? Eli Lilly Pauses COVID Treatment Trial

October 13, 2020

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KEY POINTS

Eli Lilly did not say what symptoms the ill patient developed
President Trump was given an antibody cocktail as part of his COVID treatment
AstraZeneca earlier paused it’s vaccine trial but has since restarted it in the U.K.

Eli Lilly (LLY) on Tuesday paused its coronavirus antibody trial because of a potential safety concern just one day after Johnson & Johnson (JNJ) paused its COVID-19 vaccine trial because of an unexplained illness.

The New York Times reported emails between Lilly and federal government officials concerned the trial testing the benefits of the antibody therapy on hundreds of hospitalized COVID-19 patients. All study patients also were receiving Gilead’s (GILD) trial remedy Remdesivir.

The Times said no details were provided on the number of volunteers who fell ill or any details about their illnesses.

Last week, Lilly reported just two test subjects had serious infusion reactions.

President Donald Trump received

Rheumatoid arthritis drug cuts coronavirus deaths in clinical trial, Eli Lilly says

October 8, 2020

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Eli Lilly and Company said on Thursday that there were fewer deaths among coronavirus patients who were given a combination therapy involving its rheumatoid arthritis drug and Gilead Sciences Inc’s GILD.O remdesivir drug compared to those who only received remdesivir.

The company has previously shared that the drug, baricitinib, which is marketed as Olumiant, in combination with remdesivir, was shown to cut hospitalization time for coronavirus patients. The findings come from a National Institute of Allergy and Infectious Diseases-sponsored trial dubbed the Adaptive COVID-19 Treatment Trial (ACTT-2).

The company previously shared that the drug, in combination with remdesivir, was shown to cut hospitalization time for coronavirus patients.
(Photo courtesy of Eli Lilly)

In the data shared on Thursday, the company said that the largest benefits were observed in coronavirus patients requiring supplemental oxygen, and those who required high-flow oxygen/non-invasive ventilation.

CORONAVIRUS RECOVERY TIME REDUCED BY RHEUMATOID ARTHRITIS DRUG AND REMDESIVIR,

Eli Lilly Seeks FDA Approval On Coronavirus Treatment, Potentially Easing Rush For A Vaccine

October 7, 2020

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KEY POINTS

Eli Lilly’s three trials over the summer yielded positive results in patients with mild- to moderate-cases of coronavirus
The company could have nearly 1 million doses ready for distribution by the end of 2020 with FDA approval
Temporary protections provided by the antibody treatment could potentially give pharmaceutical companies more time to develop stronger vaccines

Pharmaceutical company Eli Lilly & Co. asked the U.S. Food and Drug Administration Wednesday to authorize the use of a potential coronavirus treatment that’s shown promising results during clinical trials.

Eli Lilly asked the FDA to authorize the drug’s emergency use after results for their first three clinical trials all came back positive in people with mild- to moderate-cases of coronavirus. If approved, Eli Lilly said it could have 100,000 doses ready to go within a month and 1 million ready by the end of 2020.

However, it would not be used on

Eli Lilly Applies For Emergency Approval For Covid-19 Antibodies

October 7, 2020

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The US biotech firm Eli Lilly on Wednesday announced it was seeking an emergency use authorization (EUA) for its lab-produced antibody treatments against Covid-19, after early trial results showed they reduced viral load, symptoms and hospitalization rates.

“Our teams have worked tirelessly the last seven months to discover and develop these potential antibody treatments,” said Daniel Skovronsky, Lilly’s chief scientific officer.

“Lilly is diligently working with regulators around the world to make these treatments available,” he added.

The company said in a statement that its “combination therapy” of two antibodies working together was shown to be effective in a placebo-controlled study of 268 patients with mild to moderate Covid-19.

Their analysis showed the proportion of patients with high viral load at day 7 of their illness was 3.0 percent on the therapy, compared to 20.8 percent on the placebo arm.

Improvement in symptoms was seen as early as three days

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