Roche has announced that the phase III CAPSTONE-2 study showed treatment with baloxavir marboxil significantly reduced the time to improvement of influenza symptoms versus placebo.
This is 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. 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 and type B 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. In the subpopulation of patients 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.
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 bod. Baloxavir marboxil also reduced the use of antibiotics and incidence of influenza-related complications compared to placebo. Baloxavir marboxil had a numerically lower overall incidence of reported adverse events compared with placebo or oseltamivir.
Influenza is a hot topic and the weather starts to turn, earlier this year ILC-UK stressed the economic benefits of flu vaccinations while BioNTech & Pfizer are currently collaborating on mRNA-based influenza vaccines.
Baloxavir marboxil is a single-dose, investigational oral medicine that represents the first of a new class of antivirals with a novel proposed mechanism of action that differs from other currently available treatments. The Food and Drug Administration (FDA) accepted a New Drug Application (NDA) and granted Priority Review to baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older based on the results from CAPSTONE-1 and an earlier phase II study. If approved, baloxavir marboxil will be the first single-dose oral antiviral, and the first medicine with a novel proposed mechanism of action to treat the flu in nearly 20 years.
Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development said, “This is the first phase III trial to demonstrate a significant, clinically meaningful benefit in people at high-risk for complications from the flu for which there are no currently approved medicines. This study adds to the growing body of evidence supporting baloxavir marboxil as a potential first-in-class antiviral flu treatment, and we plan to discuss these data with health authorities around the world.”