Roche says its investigational flu drug baloxavir marboxil, in-licensed from Japan’s Shionogi, has met key goals in a late-stage trial.
Data from the Phase III CAPSTONE-2 study, which assessed the antiviral in people at high risk of complications from the flu, showed superior efficacy in the primary endpoint of time to improvement of influenza symptoms versus placebo.
Baloxavir marboxil also demonstrated superior efficacy compared to placebo and oseltamivir on a range of secondary endpoints, including viral shedding and reducing viral levels in the body, and it also significantly cut the incidence of influenza-related complications.
Also of note, the drug was well tolerated and no safety signals were identified, the firm said.
“Baloxavir marboxil is the first antiviral to show a clinically meaningful benefit in people who are most susceptible to complications from the flu, including older people and those living with certain medical conditions,” said Sandra Horning, Roche’s chief medical officer and head of Global Product Development.
“We plan to submit the results of this second positive Phase III study for baloxavir marboxil to healthcare authorities, and look forward to discussing next steps since there are no current antiviral medicines approved to specifically treat this high-risk population.”
Full results are to be presented at upcoming medical meetings.