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J&J HCV Update: AL335+ACH3102+Simeprevir Phase 2 Study
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excerpted from Achillion press release on May 3 2016
Achillion Reports First Quarter 2016 Financial Results and Provides Update on Clinical Programs
- Company provides update on HCV collaboration with Janssen; Phase 2b combination study evaluating doublet and triplet regimens for six and eight weeks anticipated to begin in Q3 2016 -http://ir.achillion.com/releasedetail.cfm?ReleaseID=968632
Update of HCV Clinical Program
⋅ Phase 2a randomized, open-label study to evaluate the safety, pharmacokinetics and efficacy of the combination of AL-335, odalasvir (ACH-3102), and simeprevir in treatment-naïve subjects with genotype 1 chronic hepatitis C
The Janssen sponsored phase 2a clinical trial evaluating all-oral regimens for durations of eight weeks and less remains ongoing. This trial is evaluating a triplet regimen, consisting of odalasvir, AL-335, and simeprevir, for durations of eight and six weeks, as well as a doublet regimen, consisting of odalasvir and AL-335, for eight weeks. Top line results from this study are expected to be released in the third quarter of the year.
⋅ Phase 2b, multicenter, randomized, open-label study to investigate the efficacy, safety and pharmacokinetics of different treatment regimens of AL-335, odalasvir, and simeprevir in treatment-naive and treatment-experienced subjects with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, and 6 infection, with and without cirrhosis
Janssen's planned global phase 2b clinical trial is expected to begin enrolling patients in the third quarter of 2016. This phase 2b clinical trial is designed to evaluate two regimens, a triplet (odalasvir, AL-335, and simeprevir) regimen and a doublet regimen (odalasvir and AL-335), for treatment durations of six and eight weeks in treatment-naïve and treatment-experienced patients with genotypes 1 - 6 HCV, including those patients with or without cirrhosis This trial is expected to enroll approximately 400 patients.
ACH-3102 http://www.natap.org/2015/EASL/EASL_143.htm
EASL: PAN-GENOTYPIC EVALUATION OF AL-335, A CLINICAL STAGE URIDINE ANALOG INHIBITOR OF HEPATITIS C VIRUS POLYMERASE - (04/18/16)
EASL: AL-335, A ONCE-DAILY PANGENOTYPIC NUCLEOTIDE HCV POLYMERASE INHIBITOR, DEMONSTRATES POTENT ANTIVIRAL ACTIVITY OVER 7 DAYS IN TREATMENT-NAïVE GENOTYPE 1-4 PATIENTS - (04/18/16)
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