Half-Year 2022 Financial and Clinical Trials Update
Xofluza (baloxavir marboxil, RG6152, S-033188)
Small molecule, novel CAP-dependent endonuclease inhibitor
Indication
Influenza
Roche
Phase/study
# of patients
Design
Phase III
miniSTONE 1 (0-1 year old)
N=30
Xofluza on Day 1 (based on body weight and age)
in healthy pediatric patients from birth to <1 year
with influenza-like symptoms
Phase III
miniSTONE 2 (1- <12 years old)
N=176
Healthy pediatric patients 1 to <12 years of age
with influenza-like symptoms
ARM A: Xofluza
ARM B: Tamiflu
Phase IIIb
CENTERSTONE
N=3,160
Reduction of direct transmission of influenza from
otherwise healthy patients to household contacts
ARM A: Xofluza
ARM B: Placebo
Primary endpoint
Status
CT Identifier
■ Safety
Safety
•
⚫ FPI Q1 2019
•
Primary endpoint met Q2 2019
.
Data presented at OPTIONS X 2019
•
Filed in US Q1 2020
•
In collaboration with Shionogi & Co., Ltd.
CAP=Catabolite Activating Protein
NCT03653364
•
.
Data published in Pediatric Infectious Disease
2020 Aug;39(8):700-705
Not approved in the US, determining path
forward with the FDA
Filed in EU Q4 2021
NCT03629184
■ Percentage of household contacts who are PCR-
positive for influenza by day 5
post randomization of index patients
■ FPI Q4 2019
NCT03969212
124
Infectious DiseasesView entire presentation