Nonclinical and clinical characterization of MAU868, a novel human-derived monoclonal neutralizing antibody targeting BK polyomavirus VP1.
Abend, J. R., et al.American Journal of Transplantation 2024 [record in progress].
Aims
The aim of this study was to report in vitro and first in-human studies assessing the safety, tolerability and pharmacokinetics of MAU868, a novel human immunoglobulin (Ig) G1 monoclonal antibody, against BK polyomavirus VP1 in healthy adults.
Interventions
Participants were randomised to receive either MAU868 or placebo.
Participants
33 healthy adults (aged 18-60 years) weighing between 40 and 120 kg.
Outcomes
The primary outcomes included safety and tolerability outcomes (adverse events and serious adverse events). Secondary outcomes were assessment of pharmacokinetics and the potential immunogenicity of MAU868.
Follow-up
182 days
CET Conclusions
This interesting paper reports in vitro and first-in-human studies of a novel human IgG1 monoclonal antibody against BK virus. In vitro studies demonstrate binding and neutralisation of infection with no evidence of resistance in long-term selection studies. The first-in-human clinical study in healthy volunteers demonstrated the pharmacokinetic profile of the drug, and the treatment was well tolerated with no major side effects at all doses. The clinical study was well designed, with randomisation and placebo control, although the exact method of randomisation and allocation concealment is not described. Given the lack of existing treatments for BK virus, this is a very promising initial study.
Data analysis
Per protocol analysis
Trial registration
N/A