Regeneron Pharmaceuticals Inc on Tuesday said that its dual antibody treatment for COVID-19 reduced symptomatic illness by four days at any level of dose tried in its clinical trial adding that the treatment also seemed to reduce hospitalizations and death by about 70 per cent compared to placebo. At any dose given, the treatment significantly reduced the patient's viral load.
"This definitive Phase 3 outcomes trial in high-risk non-hospitalized COVID-19 patients ("outpatients") met its primary endpoint, showing the investigational REGEN-COV (casirivimab with imdevimab) significantly reduced the risk of hospitalization or death by 70 per cent (1,200 mg intravenous [IV]) and 71 per cent (2,400 mg IV) compared to placebo," the company said in a statement.
The news outlet reported that 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.
"REGEN-COV also met all secondary endpoints in the Phase 3 outcomes trial, including the ability to reduce symptom duration. In addition, a compon Phase 2 trial showed that even the lowest doses tested (IV: 300 mg; subcutaneous [SC]: 600 mg) had significant viral load reductions over the first 7 study days, comparable to the 2,400 mg and 1,200 mg IV doses," the company said.
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, as reported by CNN.
"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 in a statement.
It was reported that 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 per cent of the patients were Latino/Hispc, and 5 per cent were African-Americans.
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.
On Thursday, the US FDA said that Regeneron's antibody treatment seemed to work to protect people against all of the coronavirus variants most worrying to scientists. 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, as reported by CNN.
( With inputs from ANI )
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