STOCKHOLM--(BUSINESS WIRE)--Regulatory News:
Medivir AB (STO:MVIRB) today announces that a phase IIb open-label study
of the combination of simeprevir, odalasvir and AL-335, also known as
JNJ-4178, has been initiated by Janssen Research & Development, LLC.,
part of the Janssen Pharmaceutical Companies of Johnson & Johnson
(Janssen), in treatment-naive and treatment-experienced subjects with
chronic hepatitis C virus infection without cirrhosis. This global,
multi-center study includes clinical trial sites in North America,
Europe and Asia and forms part of Janssen’s global development program
The objectives of the phase IIb study are to investigate the efficacy,
safety and pharmacokinetics of JNJ-4178/ AL-335 (800mg QD), odalasvir
(25mg QD), and simeprevir (75mg QD) in treatment-naive and
treatment-experienced non-cirrhotic subjects with chronic hepatitis C
virus genotype 1, 2, 4, 5, and 6 infection.
Patients in the study will receive the triple combination for either six
or eight weeks, and the primary efficacy endpoint will be the percentage
of patients with a sustained virological response 12 weeks after the end
of treatment (SVR12).
An ongoing phase IIa study is assessing the same triple combination in
patients with or without compensated cirrhosis.
Further information on the trial planning and conduct can be found on www.clinicaltrials.gov
with identifier NCT02765490.
Medivir is required under the Securities Markets Act to make the
information in this press release public.
The information was submitted for publication at 8.30 CET on 28 November
Medivir is a research based pharmaceutical company with a research focus
on oncology and infectious diseases. We have a leading competence within
protease inhibitor design and nucleotide/nucleoside science and we are
dedicated to develop innovative pharmaceuticals that meet great unmet
medical need. Our commercial organization provides a portfolio of
specialty care pharmaceuticals on the Nordic market. Medivir is listed
on the Nasdaq Stockholm Mid Cap List.
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