29 October 2020 - - US-based biotechnology company Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has released positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits), the company said.

The randomized, double-blind trial is measuring the effect of adding REGN-COV2 to usual standard-of-care, compared to adding placebo to standard-of-care.

A descriptive analysis from the first 275 patients was previously reported.

This data, involving an additional 524 patients, show the trial met all of the first nine endpoints in the statistical hierarchy, which assessed virologic endpoints based on viral load, seronegative status and dose group, as well as the key clinical endpoint of COVID-19 related medically-attended visits, in patients who had laboratory-confirmed COVID-19 at baseline.

Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4 grams).

Based on this finding, Regeneron is reviewing potential changes to dosing in the ongoing outpatient clinical trial given the current limited supply of REGN-COV2.

Virologic results (n=524, prospectively confirming previous 275-patient analysis):

On the primary endpoint, the average daily change in viral load through day 7 (mean time-weighted average change from baseline) in patients with high viral load (defined as greater than107 copies/mL) was a 0.68 log10 copies/mL greater reduction with REGN-COV2 compared to placebo (combined dose groups; p