Regeneron narrows window for administration of COVID-19 antibodies
IDMC advice reinforces notion that antibody therapies should be given early in infection
An IDMC’s recommendations for a study of REGN-COV2 in hospitalized COVID-19 patients reinforce the emerging picture that the optimal window to administer this class of therapies is early in infection.
An independent data monitoring committee’s recommendations regarding a trial of Regeneron’s antibody cocktail in hospitalized COVID-19 patients are reinforcing the emerging picture that the optimal window to administer this class of therapies is early in infection.
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said Friday that it would implement the committee’s recommendation to hold enrollment of patients in the study of REGN-COV2 that require high-flow oxygen or mechanical ventilation, based on a “potential safety signal and an unfavorable benefit-risk profile.” The IDMC recommended that enrollment continue among hospitalized patients with lower oxygen needs.
The company has informed FDA, which is reviewing an emergency use authorization application for the therapy to treat COVID-19 outpatients at high risk for poor outcomes. Regeneron has also informed a committee monitoring the U.K.’s RECOVERY trial of COVID-19 therapies for hospitalized patients, including REGN-COV2.
The update from Regeneron comes a few days after an announcement that NIH would halt new dosing of antibody therapy bamlanivimab from Eli Lilly and Co. (NYSE:LLY) and AbCellera Biologics Inc. in the Phase III ACTIV-3 trial of hospitalized patients due to lack of efficacy when combined with Veklury remdesivir from Gilead Sciences Inc. (NASDAQ:GILD). Testing of bamlanivimab will continue in other settings, including in ambulatory patients and as a prophylaxis.
The decisions add to the body of evidence suggesting that there may be a specific window during the course of COVID-19 during which neutralizing antibody therapies may be useful to patients. Like small molecules that inhibit viral function, neutralizing antibodies may be more efficacious when used earlier; by contrast, anti-inflammatory treatments may be more useful during later stages of the disease.
At least three companies have reported clinical data for neutralizing mAbs targeting SARS-CoV-2, and have additional studies ongoing.
Initial evidence suggests that neutralizing antibody therapies may lead to a shorter duration of symptoms, if given early. Those patients may thus benefit from receiving the therapeutics outside of hospital settings, which could require creating safe places to receive the antibodies.
Regeneron slipped $12.23 to $543.56 on Friday, shedding more than $1.3 billion in market cap.
Associate Editor Karen Tkach Tuzman contributed to this article.