Genentech has reported positive findings from the MINISTONE-2 clinical trial of Xofluza (baloxavir marboxil) for the treatment of influenza (flu) in children.
Xofluza is an oral antiviral that inhibits the cap-dependent endonuclease protein required for viral replication. It has approvals in multiple markets to treat flu types A and B in children, adolescents, and adults.
The multi-centre, randomised, double-blind Phase III trial compared the safety, efficacy, and pharmacokinetics of one dose of Xofluza to that of oseltamivir, an existing flu therapy.
The drug was observed to be well-tolerated, meeting the primary endpoint of the study.
MINISTONE-2 enrolled otherwise healthy children aged one to 12 years with confirmed influenza infection.
The primary endpoint of the trial was the proportion of patients with adverse events or severe adverse events at day 29, while secondary endpoints included pharmacokinetics, time to alleviation of influenza signs and symptoms and duration of symptoms.
In addition to the favourable tolerability profile, the trial data showed that the investigational drug was comparable to oseltamivir at minimising the duration of symptoms, including fever.
Genentech Global Product Development chief medical officer and head said: “Children need new medicines for the flu because they are at higher risk of developing the flu and more likely to have complications such as breathing problems and pneumonia.
“As a one-dose oral suspension medicine, Xofluza could potentially provide a convenient treatment option for children with the flu, and we look forward to sharing these data with health authorities around the world.”
Discovered by Shionogi, Xofluza is being developed and commercialised by the company in alliance with Roche, Genentech’s parent firm.
The drug is also being assessed in a Phase III MINISTONE-I trial in children aged less than one year.
Additional studies are being conducted in severely ill, hospitalised patients with flu and for investigating the drug’s ability to minimise transmission in otherwise healthy individuals.