Roche declares positive data from Phase III influenza treatment trial

Roche announced positive topline results from the Phase III CENTERSTONE trial of Xofluza (baloxavir marboxil), an antiviral for influenza. This single-dose oral treatment inhibits the cap-dependent endonuclease protein to reduce viral replication, infectiousness, and disease duration.

The global randomized, placebo-controlled trial involved over 4,000 participants at 272 sites worldwide, including index patients (IPs) aged five to 64 diagnosed with influenza and their household contacts (HHCs). The primary endpoint measured the rate of HHCs contracting influenza within five days post-treatment with Xofluza or placebo. Secondary endpoints included the proportion of HHCs testing positive for influenza by day five and those developing symptoms.

Findings indicated that Xofluza significantly reduced influenza transmission, achieving the primary endpoint. The treatment was well tolerated, with no new safety concerns. This evidence bolsters Xofluza's established efficacy in treating and preventing influenza, potentially improving health outcomes for individuals and communities.