Roche’s one-dose Xofluza (baloxavir marboxil) has achieved primary endpoint in phase III MINISTONE-2 study of children with flu.
The phase III trial has demonstrated that Xofluza was a well-tolerated and efficient potential treatment for flu in otherwise healthy children aged one to less than 12 years old.
Xofluza is a first-in-class and one-dose oral medicine with a novel proposed mechanism of action, which showed efficacy in a range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.
Roche’ MINISTONE-2 study assessed the proportion of patients with adverse events (AEs) or severe AEs up to day 29 in the study, showing results in line with the safety profile of Xofluza.
The trial also demonstrated the efficacy of the medicine to be comparable to oseltamivir, a treatment for children with flu.
MINISTONE-2, which is the first global phase III study for Xofluza in children, demonstrated that Xofluza was comparable to oseltamivir in relation to major secondary endpoints such as time to alleviation of influenza signs and symptoms.
The multicentre, randomised and double-blind study assessed the safety, pharmacokinetics and efficacy of one dose of Xofluza compared against oseltamivir in otherwise healthy children aged one to less than 12 years with influenza infection and displaying influenza symptoms.
Shionogi had discovered Xofluza, while it is being further developed and commercialised across the world in collaboration with Roche.
Roche global product development head and chief medical officer Dr Sandra Horning said: “Each year approximately one in three children develop flu, and their less mature immune systems mean they are slower to fight the infection and more vulnerable to complications.
“We are committed to developing new, more convenient treatment options for children with flu and look forward to sharing these data with global health authorities.”
Separately, Roche’s phase III Blockstone study demonstrated preventive treatment with Xofluza after exposure to an infected household member significantly reduced the risk of people developing flu by 86% compared to placebo.
In August this year, Roche announced that its Tecentriq (atezolizumab) plus platinum-based chemotherapy has significantly reduced the risk of disease worsening or death in people with previously untreated advanced bladder cancer in the phase III IMvigor130 study.