Ark Biosciences, a biotech company developing proprietary therapeutics for viral infection and respiratory diseases, announced today the significant progress in its phase 2 proof-of-concept study of ziresovir in the treatment of hospitalized RSV infected infants. The unblinded clinical efficacy results of part 1 of the phase 2 study will be presented at the 11th International RSV Symposium to be held in Asheville, North Carolina and further details on progress at the 6th International Society for Influenza and other Respiratory Viruses Antiviral Group Conference – Advances in Respiratory Virus Therapeutics – to be held in Washington DC, USA in November.
The anti-RSV drug ziresovir, a novel RSV F-protein inhibitor, was discovered by Roche scientists, and was licensed to Ark Biosciences in 2014. Ark Biosciences has completed multiple clinical studies with the compound, including two phase 1 clinical studies in healthy adult volunteers in Australia and China, a phase 1 human mass balance study in the United Kingdom. Ark has also been conducting a global phase 2 PoC clinical trial of ziresovir entitled VICTOR (Viral Inhibition in Children for Treatment of RSV). The study is “A Randomised, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered AK0529 to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of Single and Multiple Dosing in Hospitalized Infants with Respiratory Syncytial Virus Infection”. In the study ziresovir is being investigated for its safety and clinical efficacy in infants hospitalized for lower respiratory tract infection with naturally acquired RSV infection.
“We have made a great progress in the clinical development of ziresovir as first-line antiviral therapy for the treatment of RSV infected patients, especially hospitalized infants, which is where the greatest unmet medical need exists,” said Dr Jim Z. Wu, founder and CEO of Ark Biosciences. “We look forward to sharing the promising safety and clinical efficacy data from our phase 2 VICTOR study with the medical community at the upcoming international conferences.”
Dr Stephen Toovey, MD PhD, Chief Medical Officer of Ark Biosciences, commented that, “There is an enormous need for new medications to treat the millions of pediatric and elderly patients who suffer RSV infection every year. In the completed first part of the phase 2 VICTOR study for the treatment of infants hospitalized with RSV infection, for the first time ever, an antiviral agent, ziresovir, has demonstrated excellent safety profile and a clear dose-dependent clinical efficacy, reducing patients’ signs and symptom scores. We look forward to reporting these exciting clinical results in the upcoming 11th International RSV Symposium in Asheville and the 6th International Society for Influenza and other Respiratory Viruses Antiviral Group Conference – Advances in Respiratory Virus Therapeutics in Washington DC.”
With the development of ziresovir, Ark aims to be the industry leader in anti-RSV drug development, and to develop the first-in-disease anti-RSV drug to satisfy the extremely large unmet medical need posed by RSV infection.