Enanta Announces Eight Weeks of Treatment with AbbVie’s Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR Rates Across All Major Genotypes of Chronic Hepatitis C
- 97.5 percent of chronic HCV infected patients without cirrhosis and new to treatment across all major genotypes (GT1-6) achieved SVR12 with 8 weeks of G/P treatment
- Across the 8-week arms of three registrational studies, only 1 percent of patients experienced virologic failure, and no patients discontinued treatment due to adverse events
- G/P is an investigational, pan-genotypic, once-daily, ribavirin-free, fixed-dose combination for the treatment of chronic HCV
- G/P includes Enanta’s second protease inhibitor glecaprevir (ABT-493)
Glecaprevir (GLE), an NS3/4A protease inhibitor, is Enanta’s second
protease inhibitor being developed through its collaboration with
These new top-line data comprise results from the eight week arms of three registrational clinical trials evaluating the efficacy and safety of G/P – the ENDURANCE-1, ENDURANCE-3 and SURVEYOR-2 (Part 4) studies. Across the eight week arms of all three studies, there were no discontinuations due to adverse events (AEs). The most common AEs, occurring at a rate greater than 10 percent across these arms were headache and fatigue; and there were no AEs in any study arm at a rate greater than 20 percent. No clinically relevant laboratory abnormalities, including ALT changes, were observed.
“The SVR rates in these studies are an important step toward providing
an 8-week treatment option to HCV-infected patients without cirrhosis
who are new to treatment,” commented
Overview of preliminary results across the three studies of G/P:
|Study Name||Patient Population||
GT1 without cirrhosis, new to treatment or
GT3 without cirrhosis,
GT2, 4, 5, or 6 without cirrhosis, new to
G/P is an investigational, pan-genotypic regimen currently being
evaluated in a registrational clinical development program, and its
safety and efficacy have not been established. Additional data from the
ENDURANCE-1 and SURVEYOR-2 (Part 4) studies will be presented at The
Liver Meeting®, the Annual Meeting of the
G/P is an investigational, pan-genotypic regimen that is being evaluated
as a potential cure with 8 weeks of treatment for HCV patients without
cirrhosis and new to treatment, who make up the majority of HCV
AbbVie’s clinical development program for (G/P) was designed to investigate a faster path to virologic cure for all major HCV genotypes (GT1-6), with the goal of addressing treatment areas of continued unmet medical need. Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.
About the ENDURANCE and SURVEYOR Studies
ENDURANCE-1, ENDURANCE-3 and SURVEYOR-2 (Part 4) are open-label, multi-center, registrational studies evaluating the safety and efficacy of G/P across all major chronic HCV genotypes (GT1-6). The primary efficacy endpoint for all studies is SVR12.
ENDURANCE-1 is a randomized study designed to evaluate the safety and efficacy of 8 and 12 week treatment durations of G/P in patients with GT1 chronic HCV infection without cirrhosis and new to treatment or not cured with previous IFN-based treatments (pegIFN +/- RBV or SOF/RBV +/- pegIFN), including patients co-infected with HIV-1.
ENDURANCE-3 is a partially randomized study designed to evaluate the safety and efficacy of 8 and 12 week treatment durations of G/P in patients with GT3 chronic HCV infection without cirrhosis and new to treatment. The study has an additional active comparator arm of 12 weeks of sofosbuvir + daclatasvir (SOF+DCV). Additional data from study arms will be presented at an upcoming scientific congress.
SURVEYOR-2 (Part 4) is a single-arm study evaluating 8 week treatment duration of G/P in patients with GT2, 4-6 chronic HCV infection without cirrhosis and new to treatment or not cured with previous IFN-based treatments (pegIFN, SOF/RBV or pegIFN/SOF).
Enanta has discovered novel protease inhibitors that are members of the
direct-acting-antiviral (DAA) inhibitor classes designed for use against
the hepatitis C virus (HCV). These protease inhibitors, developed
through Enanta’s collaboration with
Enanta has also discovered EDP-305, an FXR agonist product candidate for NASH, currently in Phase 1 clinical development, as well as a cyclophilin inhibitor, EDP-494, a novel host-targeting mechanism for HCV, which is also in Phase 1 clinical development. In addition, Enanta has early lead candidates for HBV and RSV in preclinical development. Please visit www.enanta.com for more information on our programs and pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including
statements with respect to the prospects for regulatory approval filings
for AbbVie’s investigational HCV treatment regimen containing
glecaprevir (ABT-493). Statements that are not historical facts are
based on management’s current expectations, estimates, forecasts and
projections about Enanta’s business and the industry in which it
operates and management’s beliefs and assumptions. The statements
contained in this release are not guarantees of future performance and
involve certain risks, uncertainties and assumptions, which are
difficult to predict. Therefore, actual outcomes and results may differ
materially from what is expressed in such forward-looking statements.
Important factors and risks that may affect actual results include: the