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.
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.