Based on the recommendation of the independent data monitoring committee (IDMC), Regeneron Pharmaceuticals has stopped enrolling patients receiving advanced COVID-19 care in clinical trial for its REGN-COV2 antibody cocktail treatment.
Noting “a potential safety signal and an unfavorable risk/benefit profile at this time,” the IDMC recommended severely ill patients requiring high-flow oxygen or mechanical ventilation be placed on hold pending collection and analysis of further data.
The Regeneron trial will continue in outpatients and in hospitalized patients on low or no oxygen, without any recommend trial modifications from the IDMC, suggesting any safety concerns are limited to the sickest participants. Positive, prospective results for this population were announced by the company on Oct. 28 via press release (no data yet published or peer-reviewed). The company stated that in this population, REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits).
Regeneron has shared these results with the U.S. FDA, which is reviewing an Emergency Use Authorization submission for the REGN-COV2 low dose in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes.
Impact on International Clinical Trials
REGN-COV2 is part of global clinical studies, including the RECOVERY Trial (Randomised Evaluation of COVID-19 Therapy). This UK national clinical trial aims to identify treatments that may be beneficial for people hospitalized with suspected or confirmed COVID-19.
“Since REGN-COV2 is being studied in the RECOVERY trial, we have today discussed this announcement with Regeneron, with the UK Medicines & Healthcare products Regulatory Agency, and with the chair of the RECOVERY independent Data Monitoring Committee,” Professor Peter Horby and Professor Martin Landray, Co-leads, RECOVERY trial, University of Oxford, UK. “The independent Data Monitoring Committee will review the latest data from the ongoing RECOVERY trial on Thursday 5 November. In the meantime, the RECOVERY trial will continue as planned.”
Regeneron was awarded a $450 million contract from the U.S. government in June 2020 to deliver for doses of this antibody cocktail once approved. The company started scaling up manufacturing capacity earlier this year.