Roche has reported positive data from two Phase III studies, Ministone-2 and Blockstone, that evaluated Xofluza (baloxavir marboxil) for the prevention and treatment of influenza (flu).
Xofluza is an oral, single-dose flu medication discovered by Japanese pharmaceutical firm Shionogi. Roche has global rights to develop and commercialise the drug, except in Japan and Taiwan.
The multi-centre, randomised, double-blind Ministone-2 trial was performed to compare the safety, efficacy and pharmacokinetics of Xofluza with oseltamivir over five days in otherwise healthy children aged up to 12.
The study, which is claimed to be the first global Phase III study of the drug in children, met its primary endpoint of assessing the proportion of patients with adverse events or severe adverse events up to day 29.
Pharmacokinetics, duration of symptoms including fever, and time to alleviation of signs and symptoms, were the secondary endpoints of the trial.
Roche said that 46.1% of Xofluza-treated participants had at least one treatment-emergent AE versus 53.4% treated with oseltamivir.
The Xofluza’s efficacy was found to be comparable to oseltamivir. Key secondary endpoints were also comparable between the treatment arms.
Compared to oseltamivir, Roche’s drug led to a decrease in the length of time that the flu virus was released from the body by more than two days.
The Blockstone trial is a post-exposure prophylaxis study designed to assess a single dose of Xofluza as a preventive therapy for flu patients.
The primary endpoint was to assess the proportion of subjects testing positive for the flu virus and having fever along with one or more respiratory symptoms between days one and ten.
Secondary endpoints of the study were safety, tolerability, clinical efficacy and pharmacokinetics.
Data showed that the drug led to an 86% decrease in the risk of people developing flu compared to placebo.
Only 1.9% of participants treated with the drug had the infection versus 13.6% on placebo.
Xofluza’s safety profile was also comparable to that of placebo.