Phase III CAPSTONE-2 study showed baloxavir marboxil significantly reduced time to improvement of influenza symptoms.- Genentech/Roche

Genentech, a member of the Roche Group announced that the Phase III CAPSTONE-2 study showed treatment with baloxavir marboxil significantly reduced the time to improvement of influenza symptoms versus placebo (median time of 73.2 hours versus 102.3 hours; p<0.0001) in people at high risk of serious complications from the flu, which includes adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, morbid obesity or heart disease. baloxavir marboxil was well-tolerated and no new safety signals were identified. results of the study will be presented as a late-breaking oral presentation during idweek 2018 in san francisco, california on saturday, october 6, 2018 (abstract #lb16). baloxavir marboxil was discovered and developed by shionogi co., ltd., and is sold in japan under the trade name xofluza.>

The CAPSTONE-2 study also showed that baloxavir marboxil demonstrated efficacy (reduced time to improvement of influenza symptoms) in influenza type A/H3N2 (median time of 75.4 hours and 100.4 hours; p<0.05) and type b (median time of 74.6 hours and 100.6 hours; p><0.05) versus placebo. in addition, results for the overall patient population of the study showed numerically shorter time to improvement of influenza symptoms of baloxavir marboxil versus oseltamivir with a median time to improvement of symptoms of 73.2 hours for baloxavir marboxil compared with 81.0 hours for oseltamivir (p="0.8347)." in the subpopulation of people with influenza type b, a subgroup where some antiviral treatments have shown only limited efficacy or inconclusive data, baloxavir marboxil was significantly more efficacious than oseltamivir in reducing the time to improvement of symptoms (median time of 74.6 hours versus 101.6 hours; p><0.05).>

Baloxavir marboxil demonstrated efficacy compared to placebo and oseltamivir for key secondary endpoints, including reducing the time that the virus continued to be released from the body (viral shedding; median time of 48.0 hours for baloxavir marboxil versus 96.0 hours for both placebo and oseltamivir; p<0.0001). baloxavir marboxil also reduced the use of antibiotics and incidence of influenza-related complications (3.4 percent and 2.8 percent respectively) compared to placebo (7.5 percent and 10.4 percent; p="0.01" and p><0.05). baloxavir marboxil had a numerically lower overall incidence of reported adverse events (25.1 percent) compared with placebo (29.7 percent) or oseltamivir (28.0 percent).> .