October 30, 2020
The investigational antibody used to treat President Trump shows it reduced viral load and medical visits.
Regeneron reported this week it had released further data including more than 500 additional patients showing the company’s investigational antibody cocktail, REGN-COV2, reduced viral loads and medical visits. The visits were categorized as hospitalizations, emergency room, urgent care visits, and/or physician office/telemedicine visits.
“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,” the company said in a statement. “There was a 1.08 log greater reduction with REGN-COV2 treatment by day 5, which corresponds to REGN-COV2 patients having, on average, a greater than 10-fold reduction in viral load, compared to placebo.”
For those patients taking the investigational therapy, they reduced medical visits by 57% through day 29 (2.8% combined dose groups; 6.5% placebo).
In addition, in patients with one or more risk factors who were taking REGN-COV2, they saw a 72% reduction in COVID-19 related medical visits. Risk factors included being over 50 years of age, a body mass index greater than 30, cardiovascular, metabolic, lung, liver or kidney disease, or immunocompromised status.
These results are from an ongoing phase 2/3 trial in the COVID-19 outpatient setting showing REGN-COV2 met its primary and key secondary endpoints.
“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,” George Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, said this week. “We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors.”
The therapy is currently being reviewed by the US Food and Drug Administration (FDA) for an Emergency Use Authorization for low dose treatment in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes. The company has shared this new data with the federal agency.
This is also the same therapy President Trump was treated with earlier this month when he was hospitalized.
“The company’s current priority is to maintain a sufficient supply of REGN-COV2 in order to conduct rigorous clinical trials that fully evaluate its safety and efficacy,” Regeneron wrote at that time. “In addition to the clinical trial supply and product being manufactured under an agreement with the U.S. government, there is limited product available for compassionate use requests that have been approved under rare, exceptional circumstances on a case-by-case basis.”