With the REGN-COV2 antibody mixture used by President Donald Trump being touted as a cure and hit by safety concerns, the development of COVID-19 antibodies continues as it continues to push for emergency FDA authorization.
The cocktail was mistakenly called “Regeneron” and a series of tests are currently underway, including for COVID-19 patients currently hospitalized. But Friday morning, the Independent Data Monitoring Committee (IDMC) told Regeneron that for safety reasons, it needed to return the most sick patients for testing.
It said: “Based on the current potential safety signals and unfavorable risks/benefits, IDMC recommends that patients who require high-flow oxygen or mechanical ventilation be further enrolled in the group, waiting to collect and analyze more data about the registration of patients.
It does not provide detailed information about what the safety signal is. The news caused the stock to fall sharply. The news was touched for the first time, and the stock fell 2.6% before the market opened.
However, IDMC does state that the biopharmaceutical can continue to recruit hospitalized patients who do not require oxygen or low flow oxygen, because “the risks/benefits of these groups are still acceptable.” It can also continue outpatient trial work “without modification.”
The FDA is currently evaluating the rapid-use authorization nod for cocktails, especially for moderate and moderate outpatients, with higher risks. It is unclear how the news will affect this process.
A few days after the treatment indicated that the number of COVID-19-related medical visits was reduced by 57% in the early data.