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Regeneron halts enrolment of severely ill patients in COVID-19 antibody trial

Trial modified based on recommendations from independent data monitoring committee

Regeneron has announced that it has stopped enrolment of severely ill COVID-19 patients into its antibody cocktail treatment trials based on expert recommendations.

According to Regeneron, the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail COVID-19 treatment trials recommended that the current hospitalised patient study be modified.

In particular, the IDMC recommended halting further enrolment of patients requiring high-flow oxygen or mechanical ventilations after identifying potential ‘safety signals’ as well as an ‘unfavourable risk/benefit profile’.

Despite this enrolment pause, the IDMC also recommended continuing enrolment of hospitalised patients requiring no or low-flow oxygen, as the risk-benefit profile remains acceptable in this cohort.

The US Food and Drug Administration (FDA) is currently evaluating REGN-COV2 for a potential emergency use authorisation, although Regeneron has only submitted the antibody cocktail under this approval process for mild-to-moderate high-risk outpatients.

Following the IDMC recommendations, Regeneron has shared the updates with the FDA as well as the independent committee monitoring the RECOVERY trial in the UK, which is also evaluating REGN-COV2 in hospitalised patients.

Regeneron’s trial updates closely follows an announcement from Eli Lilly, which cut short a clinical trial of its antibody treatment bamlanivimab in hospitalised COVID-19 patients last week.

Lilly, in a statement released last Thursday, said that no additional COVID-19 patients in the hospitalised setting will receive the antibody treatment.

This decision was based on data suggesting that bamlanivimab is ‘unlikely’ to help this groups of patients to recover from COVID-19 infection.

Lilly initially paused the US National Institute of Allergy and Infectious Diseases (NIAID) partnered study earlier this month.

According to Reuters, a US National Institutes of Health (NIH) spokeswoman said the trial in question was paused when the independent data and safety monitoring board (DSMB) found that the antibody-treated group showed a different ‘clinical status’ after five days of treatment compared to the placebo arm.

Regeneron revealed new data last week supporting its EUA for REGN-COV2 in outpatient COVID-19 cases, saying that the antibody cocktail induced a greater than ten-fold reduction in viral load compared to placebo.

After 29 days, 2.8% of patients taking REGN-COV2 at either the 8g or 2.4g doses had a medical visit because of their symptoms, compared to 6.5% receiving placebo.

For patients with one or more risk factors, the benefits were most profound, with medical visits reduced by 72% in this patient group.

"We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors,” said George Yancopoulos, president and chief scientific officer of Regeneron.

Article by
Lucy Parsons

3rd November 2020

From: Research



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