SHANGHAI, CHINA - Ark Biosciences ("Ark" for short), a biotech company developing proprietary therapeutics for respiratory viral diseases and viral hepatitis, today announced the successful completion of phase I clinical study of its anti-respiratory syncytial virus (RSV) drug AK0529. AK0529 is a structurally novel anti-RSV drug being developed for the treatment of acute RSV infection. The orally administered drug specifically inhibits RSV replication by blocking viral entry and syncytium formation, the latter a unique viral transmission and cell-cell fusion phenomenon which gives the virus its name. AK0529 demonstrates potent antiviral activity across multiple strains of RSV in vitro and represents an important step forward in the development of effective therapeutics for this serious and often life-threatening infection. In a randomized, double-blind, placebo-controlled phase I study of orally administered AK0529, safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses were evaluated. The study was conducted in a well-known Australian clinical research unit.
“We are pleased to announce the successful completion of AK0529's phase I clinical trial," stated Dr Jim Wu, Founder and Chief Executive Officer of Ark. "This represents a significant step in the development of AK0529 as an effective first-line antiviral therapy for RSV infection in infants and the elderly". Dr Stephen Toovey, MD PhD, Chief Medical Officer of Ark, commented "We received top-line results from our AK0529 phase I study. The safety and pharmacokinetics of AK0529 were evaluated in both single and multiple ascending doses. The drug was well tolerated, with an excellent safety profile and no serious adverse events, right up to the maximum administered dose of 1200 mg". Ark is now progressing the development of AK0529, with commencement of a study in hospitalized patients and will in due course present further clinical results.
Details of the phase I clinical trial results were delivered in oral presentation at the 1st International Meeting on Respiratory Pathogens in Singapore on September 3rd, 2015 (1st ISIRV-IMRP).