Genentech Presents Positive Phase III Study Results for One-dose Xofluza in Children with the Flu.
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- US-based Genentech said that the Phase III MINISTONE-2 study showed that one-dose Xofluza (baloxavir marboxil) was a well-tolerated and effective potential treatment for the flu in otherwise healthy children aged one to less than 12 years old.
Genentech is a member of Switzerland's Roche Group (SIX: RO) (OTCQX: RHHBY).
The study met its primary endpoint, which evaluated the proportion of patients with adverse events or severe AEs up to study day 29, demonstrating results consistent with the safety profile of Xofluza.
In Xofluza-treated participants, 46.1% experienced at least one treatment-emergent AE compared to 53.4% in the oseltamivir arm.
The study also showed the efficacy of Xofluza to be comparable to oseltamivir (a proven effective treatment for children with the flu).
In addition, consistent with data in adults and adolescents, Xofluza reduced the length of time that the flu virus continued to be released from the body by more than two days compared with oseltamivir (viral shedding; median time of 24.2 hours versus 75.8 hours, respectively).
Full results of the study were presented as a late-breaking abstract during the OPTIONS X 2019 congress in Singapore on Sunday, September 1, 2019.
MINISTONE-2 is the first global Phase III study for Xofluza in children. It showed that Xofluza was comparable to oseltamivir in relation to key secondary endpoints, including time to alleviation of influenza signs and symptoms (median 138.1 hours versus 150.0 hours).
This is the fourth positive Phase III study for Xofluza, which has now demonstrated benefit in several populations (otherwise healthy, high-risk, children) and treatment settings (symptomatic, post-exposure prophylaxis).
Xofluza is being further studied in an ongoing Phase III development program, including children under one year, severely ill hospitalized people with the flu, and to assess the potential to reduce transmission of the flu from an infected person to healthy people.
MINISTONE-2 is a Phase III, multicenter, randomized, double-blind study that evaluated the safety, pharmacokinetics and efficacy of one dose of Xofluza compared with oseltamivir in otherwise healthy children aged one to less than 12 years with an influenza infection and displaying influenza symptoms (temperature of 38[degree sign]C or over, and one or more respiratory symptoms).
Participants enrolled in the study were recruited in parallel into two cohorts: patients aged five to less than 12 years and patients aged one to less than five years.
Patients in both cohorts were randomly assigned to receive one dose of Xofluza (2 mg/kg for patients under 20 kg or 40 mg for patients 20 kg or over) or oseltamivir twice a day over five days (dosing according to body weight).
The primary endpoint of the study was the proportion of patients with adverse events or severe adverse events up to study day 29. Secondary endpoints included pharmacokinetics, time to alleviation of influenza signs and symptoms and duration of symptoms, including fever.
Xofluza is a first-in-class, one-dose oral medicine with a novel proposed mechanism of action that 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.
Unlike other currently available antiviral treatments, Xofluza is the first in a new class of antivirals designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication.
Xofluza is currently approved in several countries for the treatment of influenza types A and B in children, adolescents and adults, and in the United States for the treatment of acute, uncomplicated influenza in people 12 years of age and older.
In addition, a supplemental New Drug Application for Xofluza as a one-dose oral treatment for people at high risk of complications from the flu is under review by the FDA and a decision is expected by November 4, 2019.
Xofluza is being further studied in a Phase III development program, including children under the age of one (NCT03653364), severely ill, hospitalized people with the flu (NCT03684044), as well as to assess the potential to reduce transmission of the flu from an infected person to healthy people (NCT03969212).
Xofluza was discovered by Shionogi and Co., Ltd. and is being further developed and commercialized globally in collaboration with the Roche Group (which includes Genentech in the US) and Shionogi and 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 and Co., Ltd.
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|Article Type:||Clinical report|
|Date:||Sep 3, 2019|
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