Regeneron to Stop Enrolling Very Sick COVID-19 Patients in Antibody Trials

By Reuters Staff

November 02, 2020

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

The recommendation was based on a potential safety signal and an unfavorable 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-hospitalized patients. U.S. President Donald Trump received the treatment early in his illness, before he was hospitalized, and has credited it for his recovery from COVID-19.

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

The drugmaker said it would inform the U.S. Food and Drug Administration, which is evaluating the treatment for a potential emergency use authorization (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.

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 hospitalized and non-hospitalized COVID-19 patient.

The treatment is also being tested in a trial, called RECOVERY, of hospitalized 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.