Roche announced that the phase III MINISTONE-2 study showed that one-dose Xofluza (baloxavir marboxil) was a well-tolerated and effective potential treatment for flu in otherwise healthy children aged one to less than 12 years old. The study met its primary endpoint, which evaluated the proportion of patients with adverse events (AEs) or severe AEs up to study day 29, demonstrating results consistent with the safety profile of Xofluza. In Xofluza-treated participants, 46.1% experienced at least one treatment-emergent AE compared to 53.4% in the oseltamivir arm. The study also showed the efficacy of Xofluza to be comparable to oseltamivir (a proven effective treatment for children with flu). In addition, consistent with data in adults and adolescents, Xofluza reduced the length of time that the flu virus continued to be released from the body by more than two days compared with oseltamivir (viral shedding; median time of 24.2 hours versus 75.8 hours, respectively). Full results of the study were presented as a late-breaking abstract during the OPTIONS X 2019 congress in Singapore on Sunday 1 September, 2019 (Abstract #11756).
“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,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”
MINISTONE-2 is the first global phase III study for Xofluza in children. It showed that Xofluza was comparable to oseltamivir in relation to key secondary endpoints, including time to alleviation of influenza signs and symptoms (median 138.1 hours vs. 150.0 hours).
This is the fourth positive phase III study for Xofluza, which has now demonstrated benefit in several populations (otherwise-healthy, high-risk, children) and treatment settings (symptomatic, post-exposure prophylaxis). Xofluza is being further studied in an ongoing phase III development programme, including children under one year, severely ill hospitalised people with flu, and to assess the potential to reduce transmission of flu from an infected person to healthy people.