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

(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.

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

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.

 

Reuters source:

https://www.reuters.com/article/us-health-coronavirus-regeneron-pharms/regeneron-to-stop-enrolling-very-sick-covid-19-patients-in-antibody-trials-idUSKBN27F2AY