SARS-CoV-2-neutralising antibody BGB-DXP593 in mild-to-moderate COVID-19: a multicentre, randomised, double-blind,...

Area of Science:

• Virology
• Immunology
• Clinical Pharmacology

Background:

• BGB-DXP593 is a neutralizing monoclonal antibody targeting SARS-CoV-2.
• Preclinical studies showed BGB-DXP593 effectively reduced viral RNA in animal models.
• The study evaluated BGB-DXP593's efficacy and safety in non-hospitalized COVID-19 patients.

Purpose of the Study:

• To assess the efficacy of BGB-DXP593 in reducing SARS-CoV-2 viral load in ambulatory patients.
• To evaluate the safety and tolerability of BGB-DXP593 in mild-to-moderate COVID-19 cases.
• To explore the impact of BGB-DXP593 on viral RNA levels in both nasopharyngeal swabs and saliva.

Main Methods:

• A global, randomized, double-blind, placebo-controlled Phase 2 study (NCT04551898) was conducted across 5 countries.
• Patients with recent SARS-CoV-2 infection and mild-to-moderate symptoms received BGB-DXP593 (5, 15, or 30 mg/kg) or placebo intravenously.
• The primary endpoint was the change in nasopharyngeal viral RNA copies/mL from baseline to Day 8; secondary endpoints included hospitalization rates and adverse events.

Main Results:

• No significant difference in nasopharyngeal viral RNA reduction was observed between BGB-DXP593 and placebo groups by Day 8.
• A statistically significant reduction in saliva viral RNA was noted for BGB-DXP593 at 5 mg/kg and 15 mg/kg doses.
• Hospitalization rates were numerically lower in the BGB-DXP593 group (1.5%) compared to placebo (4.3%), though not statistically significant. Treatment-emergent adverse events were similar across groups.

Conclusions:

• BGB-DXP593 was well-tolerated in ambulatory patients with mild-to-moderate COVID-19.
• While not significantly reducing viral RNA in nasopharyngeal swabs, BGB-DXP593 showed some efficacy in reducing viral RNA in saliva at specific doses.
• Further research may be needed to clarify the clinical significance of salivary viral load reduction.