Genentech's Influenza Therapy Xofluza Meets Primary Endpoint in Phase III MINISTONE-2 Trial, Paving Way for Pediatric Use

Today, Genentech, a member of the Roche Group, announced that its innovative influenza therapy Xofluza (baloxavir marboxil) met the primary endpoint in the global Phase 3 MINISTONE-2 clinical trial. The treatment demonstrated a favorable safety profile in pediatric patients aged 1 to 12 years with influenza, while significantly shortening the duration of influenza symptoms, including fever. The efficacy of Xofluza was comparable to that of the active control group. Genentech will present detailed data from this trial at an upcoming medical conference. These results are expected to expand the indicated patient population for Xofluza to include children with influenza.

Influenza is a contagious respiratory disease caused by influenza virus infection. It poses a serious threat to public health. Worldwide, there are approximately 3 to 5 million severe cases of influenza each year, resulting in about 650,000 deaths. One in three children contracts influenza annually; they are typically more infectious than adults. Therefore, treating pediatric patients not only alleviates their symptoms but may also help prevent further spread of the virus.

Xofluza, a “first-in-class” oral antiviral drug co-developed by Shionogi & Co., Ltd. of Japan and Roche, is effective with a single dose. It can treat influenza virus strains resistant to oseltamivir as well as avian influenza virus strains (H7N9, H5N1). Xofluza’s mechanism of action differs from that of currently available antiviral therapies. It inhibits viral replication by targeting the cap-dependent endonuclease in the influenza virus. In contrast, existing anti-influenza drugs act by targeting neuraminidase. Compared with these agents, Xofluza targets an earlier stage of the viral replication cycle.

▲Mechanism of Action of Xofluza (Image source: Shionogi & Co., Ltd. official website)

Last October, the FDA approved Xofluza for the treatment of uncomplicated acute influenza in patients aged 12 years and older. This is the first influenza therapy with a novel mechanism of action to be approved in 20 years.

“Children are in particular need of innovative therapies for influenza, as they are at the highest risk of contracting the flu and are more prone to complications, including respiratory problems and pneumonia. These complications result in approximately 1 million hospitalizations annually among children under the age of 5 worldwide,” said Dr. Sandra Horning, Chief Medical Officer and Head of Global Product Development at Roche. “As an oral medication, Xofluza offers a convenient treatment option for pediatric patients with influenza. We look forward to sharing these data with health authorities around the world.”

References:

[1] Genentech Announces Positive Results for First Global Phase III Study Investigating One-dose XOFLUZA (Baloxavir Marboxil) in Children With the Fluhttps://www.gene.com/media/press-releases/14799/2019-07-02/genentech-announces-positive-results-for

Headline: Express | Breakthrough New Influenza Therapy Meets Phase 3 Clinical Endpoints, Showing Promise for Treating Pediatric Patients

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