silevimig (GR1801) / Genrix Bio, China Medical System - LARVOL DELTA

Comparison of Silevimig, a Novel Bispecific Anti-Rabies Monoclonal Antibody, with Human Rabies Immunoglobulin for Post-Exposure Prophylaxis: A Phase III, Randomized, Double-Blind, Non-Inferiority Trial. (PubMed, Clin Infect Dis) - P3 | "Silevimig was non-inferior to HRIG in inducing early RVNA responses, was well tolerated, and did not interfere with vaccine-induced immunity. These findings support Silevimig as a safe and effective alternative for passive rabies post-exposure prophylaxis (ClinicalTrials, NCT05846568)."

Clinical • Head-to-Head • Journal • P3 data

Study to Evaluate GR1801's Efficacy and Safety (clinicaltrials.gov) - P3 | N=1200 | Completed | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion

Development of a novel bispecific antibody GR1801 for rabies. (PubMed, J Med Virol) - "In vivo, GR1801 provided protection equivalent to that of human RIG in golden hamsters challenged with lethal RABV. In conclusion, these findings demonstrate the neutralization potency and breadth of GR1801, which can be a promising candidate drug for rabies PEP, and a comprehensive testing against a broad spectrum of Chinese prevalent RABVs will be investigated in great detail in the future for the in vitro and in vivo studies."

Journal • Infectious Disease

Study to Evaluate GR1801's Efficacy and Safety (clinicaltrials.gov) - P3 | N=1200 | Recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

New P3 trial