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

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

(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.

“It appears a trend is emerging in the class, and it may be that neutralizing antibodies simply do not work and/or are not safe in this (hospitalized) population,” JP Morgan analyst Cory Kasimov said in a note.

Both treatments belong to a class of drugs known as monoclonal antibodies. Regeneron’s drug, which was administered to U.S. President Donald Trump before he was hospitalized, was credited by him for his recovery from COVID-19.

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

The treatment lowers virus loads in some non-hospitalized patients, the drugmaker said on Wednesday. The U.S. Food and Drug Administration is evaluating the treatment for a potential emergency use authorization (EUA) in mild-to-moderate patients at high risk for poor outcome.

Regeneron said it will inform the health regulator about the latest move. President Trump had earlier said he would push for an EUA status for it and make it free to Americans. JP Morgan’s Kasimov said he still expects the treatment to get the tag.

The antibody cocktail is being studied in four late-stage clinical studies, including the Recovery trial in the UK.

Regeneron shares were down nearly 3% at $540.87.

Reporting by Ankur Banerjee in Bengaluru; Editing by Caroline Humer and Arun Koyyur