Baloxavir marboxil meets goals in Phase III flu study

The Phase III CAPSTONE-2 study assessing the safety and efficacy of baloxavir marboxil in people at high risk of complications from the flu met the study's primary objective, and showed superior efficacy in the primary endpoint of time to improvement of influenza symptoms versus placebo, says the drug’s developer, Swiss pharma giant Roche (ROG: SIX).

The Centers for Disease Control and Prevention (CDC)  defines people at high risk for serious flu complications to include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, diabetes, or heart disease - for these people, flu can lead to hospitalization or even death., Baloxavir marboxil also demonstrated superior efficacy compared to placebo and oseltamivir for important secondary endpoints, including reducing the time that the virus continued to be released (viral shedding) and reducing viral levels in the body.

Furthermore, baloxavir marboxil significantly reduced the incidence of influenza-related complications compared to placebo. Baloxavir marboxil was well tolerated and no safety signals were identified. Full results from the CAPSTONE-2 study will be presented at upcoming medical meetings.