A descriptive analysis of Regeneron Pharmaceuticals‘ Phase I/II/III clinical trial has found that its antibody cocktail REGN-COV2 lowered viral load and the time to symptoms improvement in non-hospitalised Covid-19 patients.
The therapy also demonstrated positive trends in decreasing medical visits.
During the ongoing, randomised, double-blind trial, the combination of REGN-COV2 and usual standard-of-care is being compared to placebo plus standard-of-care.
Regeneron noted that trial participants were given a one-time infusion of 8g or 2.4g of REGN-COV2 or placebo.
Data from the descriptive analysis is based on the findings from the initial 275 patients. The analysis evaluated anti-viral activity with the therapy and is intended to detect patients who are most likely to benefit from treatment.
Safety analysis revealed that both doses of the therapy were well-tolerated, with infusion reactions found in four patients.
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Meanwhile, serious adverse events were reported in two placebo patients, one low dose patient and no high dose patients.
Regeneron Pharmaceuticals president and chief scientific officer George Yancopoulos said: “The greatest treatment benefit was in patients who had not mounted their own effective immune response, suggesting that REGN-COV2 could provide a therapeutic substitute for the naturally-occurring immune response.
“We are highly encouraged by the robust and consistent nature of these initial data, as well as the emerging well-tolerated safety profile, and we have begun discussing our findings with regulatory authorities while continuing our ongoing trials.”
This trial is part of a clinical programme, which includes studies of REGN-COV2 to treat hospitalised patients and to prevent infection in people exposed to Covid-19 patients.
More than 2,000 subjects have been recruited across the overall REGN-COV2 development programme. At least 1,300 participants will be part of the Phase II/III portion of the outpatient trial overall.
In July, Regeneron launched Phase III trials of REGN-COV2 for the treatment and prevention of Covid-19.