China-based Ark Biosciences has filed for Chinese approval of its oral respiratory syncytial virus (RSV) fusion inhibitor ziresovir for treating RSV infections in children under two years old. The submission follows positive Phase III trial results showing the enteric-coated capsule reduced bronchiolitis clinical scores by 0.8 points more than placebo at 48 hours and lowered viral load by 77% more at 96 hours in 311 hospitalised infants. Adverse events occurred in 16% of treated patients versus 13% on placebo, with no severe drug-related safety issues reported.

Ziresovir is the first RSV-specific antiviral to complete Phase III testing successfully, blocking viral entry by targeting the fusion protein and preventing syncytium formation. Developed entirely in China, the drug represents a breakthrough for paediatric RSV treatment, which currently lacks approved therapeutics globally. Full results from the multicentre trial were published in The New England Journal of Medicine, supporting ziresovir's potential as a convenient oral alternative to monoclonal antibodies (mAb) for this leading cause of infant hospitalisations.

According to PharmCube's NextBiopharm® database, three other active projects exist globally targeting RSV fusion. Click here to request a free trial for NextBiopharm®.