Regeneron to stop enrolling very sick COVID-19 patients in antibody trials

Regeneron to stop enrolling very sick COVID-19 patients in antibody trials

FILE PHOTO: The Regeneron Pharmaceuticals company logo is seen on a building at the company's
FILE PHOTO: The Regeneron Pharmaceuticals company logo is seen on a building at the company's Westchester campus in Tarrytown, New York, U.S. September 17, 2020. REUTERS/Brendan McDermid

NEW YORK: Regeneron Pharmaceuticals said on Friday (Oct 30) it would stop enrolling patients receiving advanced COVID-19 care in a trial testing its experimental antibody treatment in hospitalised patients, based on the recommendation of an independent safety board.

The recommendation was based on a potential safety signal and an unfavourable risk-benefit profile at this time, the company said. Rival Eli Lilly & Co stopped enrolling such patients based on a similar suggestion earlier this week.

The drugmaker said on Wednesday the treatment lowers virus loads in some non-hospitalised patients. US President Donald Trump received the treatment early in his illness, before he was hospitalised, and has credited it for his recovery from COVID-19.

READ: Eli Lilly COVID-19 antibody trial paused due to potential safety concern

Regeneron said it continues to enroll other types of patients for trials. The independent data monitoring committee backed the enrollment in non-hospitalised patients as well as hospitalised patients requiring either no or a low level of oxygen.

The drugmaker said it would inform the US Food and Drug Administration, which is evaluating the treatment for a potential emergency use authorisation (EUA) in mild-to-moderate patients at high risk for poor outcome.

President Trump had said he would push for an EUA for it and make it free to Americans.

READ: Regeneron antibodies in demand after Trump COVID-19 treatment, doctors seek more data

Regeneron said it remains blinded to the data - meaning it does not know which patients have received the drug and which have not - and is implementing the recommendations.

The antibody cocktail is being studied in four ongoing late-stage clinical trials, including two studies in hospitalised and non-hospitalised COVID-19 patient.

READ: Regeneron says antibody cocktail prevents and treats COVID-19 in animals

The treatment is also being tested in a trial, called RECOVERY, of hospitalised COVID-19 patients in the UK and a separate one for the prevention of the infection in people at high-risk of exposure to a COVID-19 patient.

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Source: Reuters/ta

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