Roche has announced positive topline data from the Phase III CENTERSTONE clinical trial of Xofluza (baloxavir marboxil), an antiviral treatment for influenza infection.
A single-dose oral treatment, Xofluza is designed to hinder viral replication by stopping the cap-dependent endonuclease protein, to lower the infectiousness and disease duration.
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The randomised, placebo-controlled, global trial aimed to evaluate the efficacy of a single-dose oral administration of Xofluza in curbing the spread of flu within households.
This study was conducted at 272 sites worldwide, enrolling more than 4,000 participants.
It included patients aged five to 64 years who were diagnosed with influenza, referred to as index patients (IPs), and their household contacts (HHCs).
The proportion of HHCs who contracted influenza within five days post-treatment with Xofluza or placebo was the trial’s primary endpoint.
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By GlobalDataSecondary endpoints included the proportion of HHCs who tested positive for influenza by day five and also developed symptoms.
According to the findings, the antiviral treatment was demonstrated to significantly reduce the transmission of influenza viruses.
The study also met its primary endpoint, with a single dose of Xofluza taken by IPs significantly reducing the likelihood of household members contracting the virus.
In the trial, Xofluza was found to be well tolerated without any new safety signals detected.
Roche global product development head and chief medical officer Levi Garraway said: “Building on Xofluza’s established efficacy in treating and preventing influenza after exposure, this new evidence of transmission reduction represents an important advance that could help improve health outcomes at an individual and community level.
“We look forward to discussing these data with regulatory authorities and public health organisations for influenza pandemic preparedness to bring these benefits to patients.”
In July, Roche reported positive topline data from the ongoing multi-part Phase I clinical trial of CT-996, an oral GLP-1 receptor agonist, to treat type 2 diabetes and obesity.
