SYN023 / Synermore - LARVOL DELTA

Efficacy Evaluation of Virus Clearance of SYN023 in A Murine Rabies Model - China, 2025. (PubMed, China CDC Wkly) - "These findings suggest that SYN023 could serve as a promising therapeutic agent for rabies PEP, particularly in cases in which treatment initiation is delayed. This study provides a scientific basis for future clinical trials aimed at improving rabies treatment protocols."

Journal • Preclinical • Infectious Disease

Structural basis for broad neutralization of rabies virus by an antibody cocktail SYN023. (PubMed, Emerg Microbes Infect) - No abstract available

Journal

The efficacy and safety of SYN023 (Zamerovimab and Mazorelvimab injection), the recombinant humanized anti-rabies virus monoclonal antibody mixture, combined with rabies vaccine in a WHO category III rabies post-exposure population: A randomized, double-blind, positive control, phase III clinical trial. (PubMed, Vaccine) - "This study indicates that SYN023, a monoclonal antibody product, may be used as part of rabies post-exposure prophylaxis and provides superior protection sooner after exposure than HRIG."

Clinical • Journal • P3 data

A phase 2b, Randomized, double blinded comparison of the safety and efficacy of the monoclonal antibody mixture SYN023 and human rabies immune globulin in patients exposed to rabies. (PubMed, Vaccine) - P2b | "SYN023 provided higher RVNA than HRIG soon after rabies exposure. By Day 99 post-treatment, GM RVNA with SYN023 was lower than HRIG, however, the percent of SYN023 recipients with a protective response was not inferior at this time point. No rabies cases were reported in the study. The SYN023 safety profile was acceptable."

Journal • P2b data

A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety (clinicaltrials.gov) - P3 | N=1000 | Completed | Sponsor: Synermore Biologics (Suzhou) Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

ARPEP: Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies (clinicaltrials.gov) - P2b | N=448 | Completed | Sponsor: Synermore Biologics Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Aug 2022 ➔ Dec 2021 | Trial primary completion date: Jun 2022 ➔ Dec 2021

Trial completion • Trial completion date • Trial primary completion date

ARPEP: Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies (clinicaltrials.gov) - P2b | N=448 | Active, not recruiting | Sponsor: Synermore Biologics Co., Ltd. | Trial completion date: May 2022 ➔ Aug 2022 | Trial primary completion date: Nov 2021 ➔ Jun 2022

Trial completion date • Trial primary completion date

A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety (clinicaltrials.gov) - P3; N=1000; Active, not recruiting; Sponsor: Synermore Biologics (Suzhou) Co., Ltd.; Recruiting ➔ Active, not recruiting; Trial primary completion date: May 2021 ➔ Jun 2022

Clinical • Enrollment closed • Trial primary completion date • Infectious Disease

Rabies virus neutralizing activity, pharmacokinetics, and safety of the monoclonal antibody mixture SYN023 in combination with rabies vaccination: Results of a phase 2, randomized, blinded, controlled trial. (PubMed, Vaccine) - P1/2 | "SYN023 administered with commercially available vaccines provides adequate antibody coverage beginning earlier than other commercially available RIGs with an acceptable safety profile. Some suppression of vaccine response occurred, but RVNA levels ≥ 0.5 IU/mL were maintained throughout the relevant period."

Clinical • Combination therapy • Journal • P2 data • PK/PD data • Pain

ARPEP: Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies (clinicaltrials.gov) - P2b; N=448; Active, not recruiting; Sponsor: Synermore Biologics Co., Ltd.; Trial completion date: Dec 2021 ➔ May 2022; Trial primary completion date: Feb 2021 ➔ Nov 2021

Trial completion date • Trial primary completion date

Safety, Pharmacokinetics, and Neutralizing Activity of SYN023, a Mixture of Two Novel Antirabies Monoclonal Antibodies Intended for Use in Postrabies Exposure Prophylaxis. (PubMed, Clin Pharmacol Drug Dev) - "Anti-CTB011 and anti-CTB012 antibodies occurred with no apparent effect on PK or safety. These data support the potential use of SYN023 in antirabies postexposure prophylaxis."

Clinical • Journal • PK/PD data

ARPEP: Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies (clinicaltrials.gov) - P2b; N=448; Active, not recruiting; Sponsor: Synermore Biologics Co., Ltd.; Recruiting ➔ Active, not recruiting; Trial primary completion date: Nov 2021 ➔ Feb 2021

Clinical • Enrollment closed • Trial primary completion date

A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety (clinicaltrials.gov) - P3; N=1000; Recruiting; Sponsor: Synermore Biologics (Suzhou) Co., Ltd.

Clinical • New P3 trial • Infectious Disease

Safety, pharmacokinetics and pharmacodynamics of SYN023 alone or in combination with a rabies vaccine: An open, parallel, single dose, phase 1 bridging study in healthy Chinese subjects. (PubMed, Antiviral Res) - "SYN023 at 0.3 mg/kg is relatively saf e and effective and can be selected for further clinical trials in Chinese subjects. The clinical trial registration number is CTR20190281. http://www.chinadrugtrials.org.cn/eap/clinicaltrials.searchlist?a=a&reg_no=CTR20190281."

Clinical • Combination therapy • Journal • P1 data • PK/PD data

A Bridging Study of the SYN023 on Healthy Adult Subjects (clinicaltrials.gov) - P1/2; N=33; Completed; Sponsor: Synermore Biologics (Suzhou) Co., Ltd.

Clinical • New P1/2 trial

In Vivo Efficacy of SYN023, an Anti-Rabies Monoclonal Antibody Cocktail, in Post-Exposure Prophylaxis Animal Models. (PubMed, Trop Med Infect Dis) - "While individual MAbs did not interfere with vaccine response, SYN023 at dosages of 0.1 mg/kg and above resulted in reduced neutralizing antibody titers similar to HRIG. Thus, the in vivo characterization of SYN023 supports its utility in human rabies PEP as an efficacious alternative to RIG products."

Journal • Preclinical

ARPEP: Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies (clinicaltrials.gov) - P2b; N=448; Recruiting; Sponsor: Synermore Biologics Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open