Positive results were announced from an ongoing phase 2/3 trial evaluating the investigational antibody cocktail, REGN-COV2 (Regeneron), plus standard of care, for the treatment of coronavirus disease 2019 (COVID-19) in an outpatient setting.

REGN-COV2 consists of 2 potent, virus-neutralizing antibodies that bind noncompetitively to the receptor binding domain of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, thereby blocking its interaction with the host cell. The randomized, double-blind trial compared the effects of REGN-COV2 to placebo when added to standard of care in patients with laboratory-confirmed COVID-19.

Patients were randomized 1:1:1 to receive a one-time infusion of REGN-COV2 high dose (8 grams), low dose (2.4 grams), or placebo. In September 2020, a descriptive analysis of the first 275 patients showed that REGN-COV2 reduced viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. The latest data involving an additional 524 patients confirmed earlier results demonstrating that the treatment significantly reduced viral load.

Additionally, treatment with REGN-COV2 reduced COVID-19 related medical visits by 57% through day 29 in the overall population (2.8% combined dose groups; 6.5% placebo; P =.024), and by 72% in patients with 1 or more risk factor (combined dose groups; nominal P =.0065). Findings also showed no significant difference in virologic or clinical efficacy between REGN-COV2 high dose and low dose. With regard to safety, REGN-COV2 was found to be well tolerated with numerically less frequent serious adverse events compared with placebo (0.8% high dose; 1.6% low dose; 2.3% placebo).


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“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,” said George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron.

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Results from the study have been submitted to the Food and Drug Administration for review in order to obtain an Emergency Use Authorization for REGN-COV2 low dose in adults with mild to moderate COVID-19 who are at high risk for poor outcomes.

The Company will continue the phase 3 portion of the trial in non-hospitalized patients. REGN-COV2 is also being assessed in a phase 2/3 trial for the treatment of COVID-19 in hospitalized patients, a phase 3 open-label trial of hospitalized patients, and a phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals.

For more information visit regeneron.com.

Reference

Regeneron’s COVID-19 outpatient trial prospectively demonstrates that REGN-COV2 antibody cocktail significantly reduced virus levels and need for further medical attention. [press release]. Tarrytown, NY: Regeneron Pharmaceuticals; October 28, 2020. 

This article originally appeared on MPR