Regeneron Pharmaceuticals has reported positive results from an ongoing Phase II/III seamless trial of investigational antibody cocktail, REGN-COV2, in the Covid-19 outpatient setting.
Data from the trial showed that REGN-COV2 significantly reduced viral load and patient medical visits, including hospitalisations, emergency room, urgent care visits and/or physician office/telemedicine visits.
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Designed to block infectivity of SARS-CoV-2, REGN-COV2 is a combination of two monoclonal antibodies REGN10933 and REGN10987.
The randomised, double-blind trial is analysing the effect of adding REGN-COV2 to usual standard-of-care as compared to placebo.
Last month, Regeneron reported data from the descriptive analysis of the trial of REGN-COV2 showing it reduced viral load and the time to alleviate symptoms in non-hospitalised patients with Covid-19.
The latest data, involving an additional 524 patients, showed that the trial met all the first nine endpoints.
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By GlobalDataNo significant difference in virologic or clinical efficacy between the 8g and 2.4g dose of REGN-COV2 was reported.
Regeneron Pharmaceuticals president and chief scientific officer George Yancopoulos said: “Today’s analysis, involving more than 500 additional patients, prospectively confirms that REGN-COV2 can indeed significantly reduce viral load and further shows that these viral reductions are associated with a significant decrease in the need for further medical attention.”
On the primary endpoint, the average daily change in viral load by day seven in patients with high viral load was a 0.68 log10 copies/mL greater reduction with REGN-COV2 versus placebo.
In the overall patient group with detectable virus at baseline, the average daily reduction in viral load by day seven was a 0.36 log10 copies/mL reduction with the antibody cocktail compared to placebo.
Treatment with REGN-COV2 reduced Covid-19 related medical visits by 57% by day 29.
Regeneron shared the latest data with the US Food and Drug Administration (FDA), which is reviewing an emergency use authorisation (EUA) submission for the low dose of REGN-COV2 in high-risk patients with mild-to-moderate Covid-19.
