A Japanese pharmaceutical company announced positive results from Phase II and III clinical studies of baloxavir marboxil for the treatment of influenza. Baloxavir marboxil is an investigational oral, single-dose antiviral, has a novel mechanism of action that inhibits cap-dependent endonuclease, an essential enzyme for viral replication. In non-clinical studies, baloxavir marboxil demonstrated an antiviral effect against a wide range of influenza viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1).
In the global Phase III study (CAPSTONE-1) in patients 12 years of age and older, baloxavir marboxil reduced time to alleviations of symptoms (TTAS) compared with the placebo. The median time to alleviation of symptoms was 53.7 hours with baloxavir, as compared with 80.2 hours with placebo. Additionally, there was no statistical difference in TTAS between…
