Regeneron Announces REGN-COV2 Antibody Cocktail Meets Primary and Key Secondary Endpoints in Phase 2/3 Outpatient Trial for COVID-19

On October 28, Regeneron announced that its COVID-19 neutralizing antibody cocktail therapy, REGN-COV2, met the primary and key secondary endpoints in an ongoing Phase 2/3 clinical trial. REGN-COV2 significantly reduced patients’ viral load and the need for further medical care, including hospitalization, emergency room visits, urgent care, and/or physician office/telehealth visits.

REGN-COV2 is a combination antibody therapy composed of two monoclonal antibodies targeting distinct epitopes on the SARS-CoV-2 spike protein. It is designed to bind to the SARS-CoV-2 spike protein, thereby blocking viral entry into and infection of host cells, and alleviating symptoms of COVID-19. Preclinical studies of this therapy have been published in Science. Previously released preliminary clinical trial results from Regeneron indicated that REGN-COV2 reduced viral load and shortened the time to symptom resolution in non-hospitalized patients with COVID-19 (n=275).

This randomized, double-blind clinical trial aimed to evaluate the efficacy and safety of adding REGN-COV2 to standard care compared with adding placebo to standard care. The latest data include additional data from 524 non-hospitalized patients. The trial results showed:

In terms of virological outcomes, after 7 days of treatment, the mean viral load in newly enrolled patients (n=524) was reduced by 0.36 log10 compared with the control group (p=0.0003; 1 log10 represents a 10-fold change).

In patients with higher baseline viral loads (defined as viral load exceeding 1×10⁷ copies/mL), REGN-COV2 reduced viral load by 0.68 log₁₀ compared with the placebo group (p<0.0001). On day 5 post-treatment, REGN-COV2 reduced viral load by 1.08 log₁₀ compared with the control group, indicating a more than 10-fold greater reduction in viral load relative to controls. These results demonstrate that patients with high baseline viral loads and/or low levels of neutralizing antibodies at baseline derive the greatest benefit from REGN-COV2 therapy.

In terms of clinical outcomes (n=799), 29 days after treatment, REGN-COV2 reduced COVID-19-related medical visits by 57% (2.8% in the REGN-COV2 group; 6.5% in the placebo group, p=0.024). Among patients with one or more risk factors (including age over 50; BMI greater than 30; cardiovascular, metabolic, pulmonary, hepatic, or renal disease; or immunocompromised status), REGN-COV2 treatment reduced COVID-19-related medical visits by 72% (p=0.0065).

The trial results also showed no significant difference in virologic or clinical efficacy between the high dose (8 g) and low dose (2.4 g) of REGN-COV2. Based on this finding, and given the current limited supply of REGN-COV2, Regeneron is considering changing the dosing regimen in ongoing clinical trials.

References:

[1] REGENERON'S COVID-19 OUTPATIENT TRIAL PROSPECTIVELY DEMONSTRATES THAT REGN-COV2 ANTIBODY COCKTAIL SIGNIFICANTLY REDUCED VIRUS LEVELS AND NEED FOR FURTHER MEDICAL ATTENTION. Retrieved 2020-10-29, from https://investor.regeneron.com/news-releases/news-release-details/regenerons-covid-19-outpatient-trial-prospectively-demonstrates

Source: Jike Pharmaceutical News

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