Ark Biosciences Inc. announced today that dosing with AK0529, its leading antiviral drug against respiratory syncytial virus (RSV), has commenced in infants hospitalized with RSV infection in the VICTOR (Viral Inhibition in Children for Treatment Of RSV) study. VICTOR is a multi-center Phase 2 international clinical trial with AK0529, and follows successful completion of a Phase 1 clinical trial of AK0529 in Australia, in which the drug showed itself to be well tolerated, safe, and in which the drug displayed predictable pharmacokinetics. AK0529 is being developed for the treatment of acute RSV infection, having demonstrated potent anti-viral activity across multiple strains and clinical isolates of RSV in preclinical studies. "The commencement of dosing in hospitalized RSV infants represents a big step forward in the development of AK0529, and towards filling the enormous unmet medical need that RSV infection poses," said Dr. Jim Wu PhD, Chief Executive Officer of Ark Biosciences, "especially given the fact that seasonal RSV infection is a leading cause of infant and childhood hospitalization".
VICTOR is a randomized, double-blind, placebo-controlled, multicenter international study that evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effect of single and multiple doses of AK0529 in infants hospitalized with RSV infection. On completion, approximately 80 patients will have been enrolled and given single or multiple doses of AK0529 or placebo. This study has been approved by stringent regulatory authorities and is ongoing in several leading children’s hospitals. “From the results obtained to date, Ark Biosciences believes AK0529 should progress to become an efficacious treatment for RSV infection", said Dr. Stephen Toovey, MD, PhD, Chief Medical Officer of Ark Biosciences, "and we look forward to completion of the VICTOR study in 2017".