Regeneron Pharmaceuticals said Friday it will halt a clinical study on its antibody-drug on some of the sickest COVID-19 patients because of a potential safety concern. This development signifies another setback in the quest for scientists to develop a treatment that works among patients in the advanced stage of the disease.
The move is coming on the heels of a recommendation from an independent data monitoring committee (IDMC), which assesses data and results from clinical trials and gives recommendations on when to pause a study.
“Based on a potential safety signal and an unfavorable risk/benefit profile at this time, the IDMC recommends further enrollment of patients requiring high-flow oxygen or mechanical ventilation be placed on hold pending collection and analysis of further data on patients already enrolled,” Regeneron stated.
However, the company said it was going ahead with the enrollment of hospitalized patients who don’t require oxygen or are on low-flow oxygen; and was also continuing with its outpatient trial, which proved to reduce virus levels and the need for further medical intervention.
Regeneron said it would seek emergency use authorization from the US Food and Drug Administration for use of the antibody-drug in mild-to-moderate patients outside of clinical settings at high risk for poor outcomes. The FDA is currently accessing the company’s antibody-drug.
The drug, named REGN-COV2, was used recently to treat President Donald Trump who had high praises for the drug, describing it as a miracle and cure, The Hill reports.
The company did not release additional information on why trials were being paused for patients with severe cases of COVID-19. However, researchers have always posited that antibody treatments will be potent if administered on patients very early in the course of the disease. They base their recommendation on the treatment modality, which works by preventing the virus from attacking human cells and multiplying.
When a patient is in the late stage of the disease, inexorable progress such as organ damage and severe inflammation has already taken place, making it difficult for subsequent antibody treatments to do any good. That is why doctors resort to dexamethasone and other steroids to mitigate the reaction of the immune system.
Several weeks back, a different monitoring board had recommended halting enrollment in a study testing an Eli Lilly antibody-drug due to safety concerns in hospitalized patients.