Genentech, part of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced positive topline results from the Phase III CENTERSTONE study of Xofluza® (baloxavir marboxil). The study showed that a single oral dose of Xofluza significantly reduced the transmission of influenza viruses among household contacts of infected individuals. The treatment was well tolerated, with no new safety concerns reported.
The CENTERSTONE study is the first global Phase III trial to demonstrate a reduction in influenza transmission with an antiviral used for treating respiratory viral illnesses. This new data could enhance the benefits of Xofluza, which is currently approved for treating influenza symptoms and preventing infection after exposure. The topline results will be presented at the 2024 OPTIONS XII for the Control of Influenza Congress in Brisbane, Australia (September 29 – October 2).
“Building on Xofluza’s proven effectiveness in treating and preventing influenza, this new evidence of reduced transmission is a significant advancement that could improve health outcomes on both individual and community levels,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “We look forward to discussing these findings with regulatory authorities and public health organizations to enhance influenza pandemic preparedness and bring these benefits to patients.”
Influenza remains a major public health challenge, with up to 41 million infections, thousands of hospitalizations, and 51,000 deaths annually in the U.S. The co-circulation of multiple respiratory viruses, including COVID-19, makes early diagnosis and treatment of influenza crucial for effective control.
The CENTERSTONE study, supported in part by federal funds from the U.S. Department of Health and Human Services and the Biomedical Advanced Research and Development Authority, investigated the efficacy of a single dose of Xofluza taken within 48 hours of symptom onset to reduce influenza transmission within households. Conducted across 272 sites globally with over 4,000 participants, the study assessed the impact on household contacts of infected individuals. The primary endpoint was the proportion of contacts who tested positive for influenza within five days of treatment, while the secondary endpoint measured the proportion who developed symptoms by Day five.
About CENTERSTONE:
CENTERSTONE (NCT03969212) was a global Phase III trial evaluating single-dose Xofluza for reducing influenza transmission. The study involved healthy patients aged five to 64, diagnosed with influenza, and assessed the impact on their household contacts. The randomized, placebo-controlled trial was designed with input from the U.S. Food and Drug Administration and influenza experts.
About Xofluza® (baloxavir marboxil):
Xofluza is a first-in-class, single-dose oral antiviral that blocks viral replication by inhibiting the cap-dependent endonuclease protein. It is effective against a range of influenza viruses, including strains resistant to oseltamivir. Approved in over 80 countries for treating uncomplicated influenza types A and B, Xofluza is also used for post-exposure prophylaxis. Developed by Shionogi & Co., Ltd. and commercialized globally by Roche (including Genentech in the U.S.), Xofluza represents a significant innovation in influenza antiviral treatments.
