WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today reported
that AbbVie announced high SVR rates were achieved with 8 weeks of
treatment with its investigational, once daily, ribavirin-free,
pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) in patients with
challenging-to-treat genotype 3 (GT3) chronic hepatitis C virus (HCV)
infection. In results from AbbVie’s Phase 3 ENDURANCE-3 study, 95
percent (n=149/157) of GT3 chronic HCV-infected patients without
cirrhosis and who were new to treatment achieved sustained virologic
response at 12 weeks post-treatment (SVR12) following 8 weeks
of treatment with G/P.1 These results will be featured as an
oral presentation today at The International Liver Congress™ (ILC) 2017
in Amsterdam, The Netherlands.
In addition to evaluating 8 weeks of treatment with G/P, the ENDURANCE-3
study was designed to evaluate whether 12 weeks of G/P treatment is
non-inferior to 12 weeks of sofosbuvir plus daclatasvir (SOF+DCV), a
current standard of care for GT3 chronic HCV-infected patients.1
SVR12 rates of 95 percent were seen in both 8 weeks
(n=149/157) and 12 weeks (n=222/233) of treatment with G/P.1 Additionally,
12 weeks of treatment with G/P was demonstrated to be non-inferior to 12
weeks of treatment with SOF+DCV (97 percent, n=111/115).1
GT3 is the second most common genotype globally, accounting for 18
percent of patients worldwide and 26 percent of patients in Europe.2
Patients with GT3 HCV have more rapid disease progression, with the
highest rates of associated fibrosis, steatosis (fatty liver), and
hepatocellular carcinoma (HCC).3 Treatment guidelines with
current standards of care recommend 12 weeks of treatment in GT3
patients without cirrhosis and who are new to treatment.4
Full results from ENDURANCE-3 are the latest to be released from
AbbVie’s registrational studies in its G/P clinical development program,
designed to investigate a faster path to virologic cure* for all major
HCV genotypes (GT1-6) and with the goal of addressing areas of continued
In the ENDURANCE-3 study, no patients who received 8 weeks of G/P
discontinued treatment due to adverse events (AEs).1 AEs were
mostly mild (71 percent) in patients receiving both 8 and 12 weeks of
G/P. The most common AEs (=10 percent) in patients receiving 8 weeks and
12 weeks of G/P were headache (20 and 26 percent), fatigue (13 and 19
percent) and nausea (12 and 14 percent), respectively and with patients
receiving 12 weeks of SOF+DCV treatment (headache 20 percent, fatigue 14
percent and nausea 13 percent).1
Authorization applications for G/P are currently under review by
regulatory authorities around the world. G/P has been granted
accelerated assessment by the European Medicines Agency, and priority
review designations by the U.S. Food and Drug Administration and
Japanese Ministry of Health, Labour and Welfare. G/P is an
investigational regimen and its safety and efficacy have not been
The ENDURANCE-3 study will be featured in the official ILC press
conference on Friday, April 21 from 11:30 a.m. - 12:30 p.m. local time.
About the ENDURANCE-3 Study
ENDURANCE-3 is a Phase 3,
open-label, active-controlled study evaluating patients who are new to
treatment with HCV GT3 infection without cirrhosis. The study included
505 patients who were randomized to receive either 12 weeks of G/P (Arm
A, n= 233) or 12 weeks of SOF+DCV (Arm B, n=115), with subsequently
enrolled patients receiving 8 weeks of G/P (Arm C, n=157). The primary
endpoint was the percentage of patients achieving SVR12. The rate of
virologic failure was 1.7 percent (n=4/233) in Arm A, 0.8 percent
(n=1/115) in Arm B and 3.8 percent (n=6/157) in Arm C.
Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov.
G/P is an investigational, pan-genotypic regimen
that is being evaluated by AbbVie as a potential cure in 8 weeks for HCV
patients without cirrhosis and who are new to treatment with
direct-acting antivirals (DAAs)**, who make up the majority of HCV
patients. AbbVie is also studying G/P in patients with specific
treatment challenges, such as patients with genotype 3 HCV, patients who
were not cured with previous DAA treatment and those with chronic kidney
disease, including patients on dialysis.
G/P is an investigational, once-daily regimen that combines two distinct
antiviral agents in a fixed-dose combination of glecaprevir (300mg), an
NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor.
G/P is dosed once-daily as three oral tablets.
*Patients who achieve a sustained virologic response at 12 weeks post
treatment (SVR12) are considered cured of hepatitis C.
**Patients who are treatment-naive or had prior treatment experience
with IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN).
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on the following
disease targets: non-alcoholic steatohepatitis (NASH)/ primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with AbbVie, include paritaprevir, part of
AbbVie’s currently marketed HCV regimens, and glecaprevir (ABT-493),
Enanta’s second protease inhibitor product, which AbbVie is developing
as part of its investigational, pan-genotypic HCV regimen of
glecaprevir/pibrentasvir (G/P) now in registration in the U.S., the E.U.
and Japan. Royalties and any further milestone payments from this
collaboration will provide additional funding for Enanta’s earlier
development programs, including its Phase 1 FXR agonist program for
NASH/PBC, and its preclinical programs for HBV and RSV. Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.
Forward Looking Statements
This press release contains
forward-looking statements, including statements with respect to the
prospects for AbbVie’s G/P regimen for HCV. 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 efforts of AbbVie (our collaborator developing glecaprevir)
to obtain regulatory approvals of its glecaprevir/pibrentasvir (G/P)
combination and commercialize it successfully; the regulatory and
marketing efforts of others with respect to competitive treatment
regimens for HCV; regulatory and reimbursement actions affecting G/P,
any competitive regimen, or both; the need to obtain and maintain patent
protection for glecaprevir and avoid potential infringement of the
intellectual property rights of others; and other risk factors described
or referred to in “Risk Factors” in Enanta’s most recent Form 10-K for
the fiscal year ended September 30, 2016 and other periodic reports
filed more recently with the Securities and Exchange Commission. Enanta
cautions investors not to place undue reliance on the forward-looking
statements contained in this release. These statements speak only as of
the date of this release, and Enanta undertakes no obligation to update
or revise these statements, except as may be required by law.
1 Foster, GR et al. ENDURANCE-3: safety and efficacy of
glecaprevir/pibrentasvir compared to sofosbuvir plus daclatasvir in
treatment-naïve HCV genotype 3-infected patients without cirrhosis.
Presented at The International Liver Congress™ (ILC) in Amsterdam, The
Netherlands, April 19-23, 2017.
2 Petruzziello, A. et al. Global epidemiology of hepatitis C
virus infection: An up-date of the distribution and circulation of
hepatitis C virus genotypes. World J Gastroenterol. 2016; 22(34):
3 Asselah T, Thompson AJ, Flisiak R, Romero-Gomez M,
Messinger D, Bakalos G, et al. (2016) A Predictive Model for Selecting
Patients with HCV Genotype 3 Chronic Infection with a High Probability
of Sustained Virological Response to Peginterferon Alfa-2a/Ribavirin.
PLoS ONE 11(3): e0150569. doi:10.1371/journal.pone.
4 EASL Recommendations on Treatment of Hepatitis C 2016. J
Hepatol (2016), http://dx.doi.org/10.1016/j.jhep.2016.09.001.