Regeneron : IDMC Recommends To Hold Enrollment In Hospitalized High Risk COVID-19 Patients

(RTTNews) - Regeneron Pharmaceuticals Inc. (REGN) said Friday that the independent data monitoring committee or IDMC for the REGN-COV2 antibody cocktail treatment trials for COVID-19 has recommended to hold further enrollment in hospitalized patients requiring high-flow oxygen or mechanical ventilation.

The committee has also recommended to hold analysis of further data on patients already enrolled.

The recommendation is based on a potential safety signal and an unfavorable risk/benefit profile at this time, the company said in a statement.

However, the committee has recommended to continue enrollment of hospitalized patients requiring either no or low-flow oxygen as the risk/benefit remains acceptable in those cohorts. Finally, it recommends continuation of the outpatient trial without modification.

Regeneron said it remains blinded to the data and is implementing the IDMC recommendations.

The company will inform the U.S. Food and Drug Administration, which is currently evaluating REGN-COV2 for a potential Emergency Use Authorization in mild-to-moderate outpatients at high risk for poor outcomes.

The company will also share the recommendation with the independent committee monitoring the RECOVERY trial in the UK, which is evaluating REGN-COV2 in hospitalized patients.

REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. and Roche will develop, manufacture and distribute it outside the U.S.