Regeneron Pharmaceuticals Inc said Tuesday its dual antibody treatment for Covid-19 reduced symptomatic illness by four days at any level of dose tried in its clinical trial.
The treatment also seemed to reduce hospitalizations and death by about 70% compared to placebo, the company said.
At any dose given, the treatment significantly reduced the patient’s viral load.
Monoclonal antibodies are lab-made immune system proteins that are infused to boost a patient’s immune response to fight disease. The Covid-19 treatments seem to work best early in the course of an infection. The treatments are also being tested to see if they can prevent infection.
Regeneron’s treatment has already been authorized for use at a higher dose by the US Food and Drug Administration (FDA) treatment. It was used to treat former President Donald Trump when he developed Covid-19 last year.
The pharmaceutical company said it would now seek FDA emergency use authorization for its antibody cocktail at a lower dose in light of the latest trial data. The move could essentially double manufacturing capacity.
“We will rapidly discuss the new data with regulatory authorities and request that the 1,200 mg dose be added to the US emergency use authorization, in order for the anticipated REGEN-COV supply to be available to treat even more patients,” said Dr. George Yancopoulos, Regeneron’s President and Chief Scientific Officer.
This late-stage trial involved nearly 5,000 non-hospitalized patients. Each had at least one underlying condition that would make them more vulnerable to severe Covid-19. The trial also had a diverse patient population. About 35% of the patients were Latino/Hispanic, and 5% were Black.
The results are not published in a journal, nor are they peer-reviewed, but the company said it plans to submit the results for peer review as soon as possible.
Regeneron isn’t the only company working on an antibody treatment. Drugmaker Eli Lilly has two authorized treatments, but they may not work as well against some of the variants.
The FDA had reviewed research done on the mutations that characterize several of the new variants. None of the experiments involved live, infected patients, but the FDA said the finding were serious enough to warrant a change to the emergency use authorizations that were granted to the products.