Regeneron Pharmaceuticals is set to resume its UK-based RECOVERY trial for analysing its REGN-COV2 antibody cocktail treatment trials in hospitalised patients with COVID-19, notified the independent data monitoring committee (DMC).
The company had suspended enrolment of patients for its antibody treatment trials last week after the DMC signalled for a potential safety signal and an unfavourable risk/benefit profile. The enrolment was particularly restricted for patients receiving advanced care who required high-flow oxygen or mechanical ventilation.
However, based on the latest development the committee has reviewed available safety and efficacy data for a group of 15,545 randomised patients. This also included 325 patients in the arm randomised to receive either the investigational antibody cocktail treatment REGN-COV2 for the disease or control.
“In the light of these data and the available external information, we see no cogent reason to modify the protocol or intake to the study. We recommend continuing recruitment of eligible patients to all arms of the trial.” informed the DMC.
REGN-COV2 is a combination of two monoclonal antibodies REGN10933 and REGN10987, designed to block the infectivity of SARS-CoV-2, the virus that causes COVID-19.
A grant to the University of Oxford supported the RECOVERY trial, while the US Biomedical Advanced Research and Development Authority (BARDA) is funding REGN-COV2’s development and manufacturing.
In August, Regeneron teamed up with Roche to increase the global supply of the cocktail treatment beginning next year. On obtaining approval, Roche will develop, manufacture and distribute the cocktail treatment outside the US.