Investigational Therapy Reduces Viral Load in Non-Hospitalized COVID-19 Patients

Regeneron announced late yesterday its positive data from its trial looking at its investigational antibody cocktail, REGN-COV2, showing it reduced viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19.

REGN-COV2 reduced seronegative patients’ viral load through Day 7. The mean time-weighted-average change from baseline nasopharyngeal (NP) viral load through Day 7 in the seronegative group was a 0.60 log10 copies/mL greater reduction (p=0.03) in patients treated with high dose, and a 0.51 log10 copies/mL greater reduction (p=0.06) in patients treated with low dose, compared to placebo.

"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,” George Yancopoulos, MD, PhD, president and Chief Scientific Officer of Regeneron, said. “These patients were less likely to clear the virus on their own, and were at greater risk for prolonged symptoms. 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. In addition to having positive implications for REGN-COV2 trials and those of other antibody therapies, these data also support the promise of vaccines targeting the SARS-CoV-2 spike protein."

REGN-COV2 is a combination of 2 monoclonal antibodies designed to block infectivity of SARS-CoV-2.

The analysis comes from the first 275 patients enrolled in the trial and was designed to evaluate anti-viral activity with the investigational therapy and identify patients most likely to benefit from treatment.

For this patient cohort, approximately 56% were Hispanic, 13% were African American. And 64% had one or more underlying risk factors for severe COVID-19, including obesity (more than 40%).On average, patients were 44 years of age. In total, 49% of participants were male and 51% were female

Patients in the trial were randomized 1:1:1 to receive a one-time infusion of 8 grams of REGN-COV2 (high dose), 2.4 grams of REGN-COV2 (low dose) or placebo.

The next cohort has already been enrolled.

Trial organizers are looking to recruit at least 1300 patients for the phase 2/3 portion of the outpatient trial. Trial participants will be followed for 29 days, with viral shedding in the upper respiratory tract assessed approximately every 2-3 days in the phase 2 portion of the tria.

Along with this study, Regeneron’s therapy is being studied in a phase 2/3 clinical trial for hospitalized patients, the phase 3 open-label RECOVERY trial of hospitalized patients in the United Kingdom and a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals.

Recruitment in all the trials is ongoing.