Efficacy and Safety of Treatment with an Anti-M2e Monoclonal Antibody in Experimental Human Influenza

October 19, 2014 2:35 pm

Journal of Infectious Diseases, 3 October 2014

Abstract

Background. The efficacy of TCN-032, a human mAb targeting a conserved epitope on M2e, was explored in experimental human influenza.

Methods. Healthy volunteers were inoculated with influenza A/Wisconsin/67/2005 (H3N2) and received single dose of study drug, TCN-032 or placebo 24 hours later. Subjects were monitored for symptoms, viral shedding and safety, including cytokine measurements. Oseltamivir was administered 7 days after inoculation.

Results. While the primary objective of reducing the proportion of subjects developing any Grade 2 or greater influenza symptom, or pyrexia, was not achieved, TCN-032-treated subjects showed 35% reduction (p=0.047) in median total symptom AUC (Days 1-7) and 2.2 log reduction in median viral load AUC (Days 2-7) by qPCR (p=0.095) compared to placebo subjects. TCN-032 was safe and well tolerated with no additional safety signals following administration of oseltamivir. Serum cytokine levels (IFN-γ, TNF-α, IL-8, IL-10) were similar in both groups. Genotypic and phenotypic analyses showed no difference between virus derived from subjects after TCN-032 treatment and parental strain.

Conclusions. These data support that TCN-032 may provide immediate immunity and therapeutic benefit in influenza A infection, with no apparent emergence of resistant virus. TCN-032 was safe with no evidence of immune exacerbation based on serum cytokine expression.

Authors.

Eleanor L. RamosJennifer L. MitchamTeri D. Koller, Aurelio BonaviaDale W. UsnerGanesh BalaratnamPaul Fredlund Kristine M. Swiderek

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