Roche Announces Phase III CENTERSTONE Study of Xofluza Significantly Reduces the Transmission of Influenza Viruses

Roche Announces Phase III CENTERSTONE Study of Xofluza Significantly Reduces the Transmission of Influenza Viruses

By, Admin 20 September 2024

Roche announces phase III CENTERSTONE study of Xofluza significantly reduces the transmission of influenza viruses

Overview

Roche announced positive topline results of the phase III CENTERSTONE study of Xofluza (baloxavir marboxil), an antiviral, showing a reduction in the transmission of influenza viruses. The study met its primary endpoint, demonstrating that a single, oral dose of Xofluza taken by people infected with influenza significantly reduced the likelihood of others in their household contracting the virus. Xofluza was well tolerated with no new safety signals identified.

CENTERSTONE Study

  • CENTERSTONE is the first global phase III study to show a transmission reduction benefit with an antiviral used in the treatment of a respiratory viral illness. 
  • This new data may add to the benefits of Xofluza, which is currently approved for treating symptoms and preventing infection following virus exposure. 
  • The topline results will be presented at the 2024 OPTIONS XII for the Control of Influenza congress (29 September - 2 October, Brisbane, Australia).

From Roche’s Chief Medical Officer

  • 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,” said Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development. 
  • We look forward to discussing these data with regulatory authorities and public health organisations for influenza pandemic preparedness to bring these benefits to patients.

About Influenza

  • Influenza is one of the most common yet serious infectious diseases, representing a significant burden to public health. 
  • Every year, seasonal influenza infects an estimated one billion people and causes millions of hospitalisations and up to 650,000 deaths globally. 
  • With the co-circulation and burden of multiple respiratory viruses (including Covid-19) infecting individuals within and outside of the winter season, it is more important than ever that influenza is not underestimated. 
  • For the effective control of both seasonal and pandemic influenza, early diagnosis and treatment is critical.

The CENTERSTONE study has been partially supported with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Other Transaction Agreement number: HHSO100201800036C.

About CENTERSTONE Study

  • The CENTERSTONE study [NCT03969212] was a global phase III trial investigating the efficacy of single-dose Xofluza, taken within 48 hours of symptoms onset, to reduce the onward transmission of influenza within households. 
  • The study ran across 272 sites across the globe, with over 4,000 participants, and involved otherwise healthy patients from five to 64 years who had been diagnosed with influenza via a polymerase chain reaction (PCR) or rapid influenza diagnostic test, known as index patients (IPs) and those within their household (known as household contacts, HHCs). 
  • The primary endpoint was the proportion of HHCs who tested positive for influenza within five days after the IP had been treated with either Xofluza or placebo. 
  • The secondary endpoint looked at the proportion of HHCs who tested positive for influenza by day five and developed influenza symptoms. 
  • The design of this randomised, placebo-controlled trial was developed with inputs from the US FDA and leading experts in influenza.

About Xofluza

  • Xofluza is a first-in-class, single-dose oral medicine with an innovative mechanism of action designed to block viral replication by inhibiting the cap-dependent endonuclease protein, potentially reducing the duration of infectiousness and disease. 
  • Xofluza’s mechanism of action has demonstrated efficacy in a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.

Xofluza: Approvals

  • Xofluza is approved in more than 80 countries for the treatment of uncomplicated influenza types A and B. 
  • In Europe, Xofluza is approved for the treatment of influenza in otherwise healthy patients and as a preventative treatment (post-exposure prophylaxis). 
  • Xofluza represents the first innovation in mechanism of action for an influenza antiviral approved in almost 20 years for treatment in children, adolescents and adults.

Benefit of Xofluza

Robust clinical evidence has demonstrated the benefit of Xofluza in several populations (otherwise healthy, children and post-exposure prophylaxis in individuals aged one year and above). Xofluza was also studied in a phase III development programme in children under the age of one (NCT03653364).

Xofluza Discovery

  • Xofluza was discovered by Shionogi & Co., Ltd. and is being further developed and commercialised globally in collaboration with the Roche Group (which includes Genentech in the US) and Shionogi & Co., Ltd. 
  • Under the terms of this agreement, Roche holds worldwide rights to Xofluza excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co., Ltd.

About Influenza

  • Influenza is a serious infectious disease and represents a significant burden to public health. 
  • Seasonal epidemics result in an estimated one billion cases, millions of hospitalisations and up to 650,000 deaths globally every year. 
  • Roche has a long history of developing transformative medicines that contribute to public health. 
  • We are committed to bringing innovation in the field of infectious diseases, including influenza. 
  • Tamiflu (oseltamivir) has made a significant difference in the treatment of both seasonal influenza and pandemic management, and we are proud to have brought this innovative medicine to patients.
  • Roche is committed to addressing the unmet need in this area through its agreement with Shionogi & Co., Ltd. to develop and commercialise Xofluza (baloxavir marboxil).

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