Sep. 23, 2015
Shanghai-based Ark Biosciences announced on September 23, 2015 that the phase 1 clinical study of its anti-respiratory syncytial virus (RSV) drug AK0529 was successfully completed. 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 1 study of orally administered AK-0529, 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.