Regdanvimab shows potential for mild-to-moderate COVID-19
3 days ago
The monoclonal antibody regdanvimab showed promise in the treatment of patients with mild-to-moderate* COVID-19, a pivotal phase II/III trial has shown.
An in vivo study has reported the therapeutic benefit of regdanvimab against the B.1.351 variant (first identified in South Africa), which has now been classified by the WHO as Beta. [Biochem Biophys Res Commun 2021;566:135-140]
“[Our findings showed that] regdanvimab reduced the rate of hospitalization or requirement of oxygen supplementation, with the greatest benefit seen in patients at high risk of progressing to severe COVID-19,” said Dr Oana Sandulescu from the National Institute for Infectious Diseases “Prof Dr Matei Bals”, Bucharest, Romania, who presented the findings at ECCMID 2021.
The study comprised 1,315 adult patients (median age 48 years, 51 percent male, 67 percent high-risk**) with mild-to-moderate SARS-CoV-2 infection who had symptom onset within 7 days prior to enrolment. Patients were randomized 1:1 to receive either regdanvimab 40 mg/kg or placebo on top of the standard regimen in the participating clinical centres. [ECCMID 2021, abstract 4650]
The proportion of patients progressing to severe COVID-19 up to day 28 (requiring hospitalization, oxygen therapy) or to death due to SARS-CoV-2 infection was lower in the regdanvimab vs placebo arm, both in the high-risk (3.1 percent vs 11.1 percent; risk difference, –8 percent) and overall cohorts (2.4 percent vs 8.0 percent; risk difference, –5.9 percent; p<0.0001 for both). These results translate to a 70–72 reduction in the risk of the composite outcome, said Sandulescu.
Regdanvimab also significantly shortened time to clinical recovery up to day 14 vs placebo in the high-risk group (median, 9.3 days vs not reached; clinical recovery ratio, 1.58) and the overall cohort (median, 8.4 vs 13.2 days; clinical recovery ratio, 1.50; p<0.0001 for both). Regdanvimab cut the time to clinical recovery by almost 5 days, noted Sandulescu.
More regdanvimab vs placebo recipients experienced clinical recovery up to day 14 in both the high-risk (63 percent vs 49 percent) and overall cohorts (66 percent vs 52 percent).
An exploratory virologic assessment also showed greater reductions from baseline viral load titre with regdanvimab vs placebo at day 7 (–2.77 vs –2.24 log10cp/mL).
There were similar fractions of regdanvimab vs placebo recipients reporting ≥1 treatment-emergent AEs (TEAEs, 30 percent vs 31 percent) and grade ≥3 TEAEs (9 percent vs 11 percent). Antidrug antibody positive rate was low in the regdanvimab vs the placebo arm (1.4 percent vs 4.5 percent), with no antibody-dependent enhancement reported. There were no drug discontinuations nor adverse events of clinical relevance including infusion-related reactions.
“As many hospitals across the globe now exceed their ability to accommodate patients due to COVID-19, it is critical that we use every resource to reduce the burden on the healthcare system,” said Dr HoUng Kim from Celltrion Healthcare, Incheon, Korea, in a press release.
“This trial provides conclusive results demonstrating [the potential of] regdanvimab to improve outcomes in people with mild-to-moderate COVID-19 and significantly reduce the risk of hospitalization and death. We look forward to continuing to work with regulators around the world to make regdanvimab available to more patients in need,” added Kim.