NORTH CHICAGO, Ill.,
Jan. 11, 2016 /PRNewswire/
-- AbbVie (NYSE: ABBV), a global biopharmaceutical company,
today announced the initiation of six global Phase 3 clinical
studies evaluating the safety and efficacy of its all-oral,
once-daily, ribavirin-free investigational hepatitis C virus (HCV)
regimen, ABT-493, an NS3/4A protease inhibitor, and ABT-530, an
NS5A inhibitor, in patients with genotypes 1-6 (GT1-6) chronic HCV
infection.
"We believe AbbVie's work in hepatitis C has contributed to the
transformation of HCV care over the last few years," said
Michael Severino, M.D., executive
vice president, research and development and chief scientific
officer, AbbVie. "Our journey continues with the initiation of
these Phase 3 studies, which we hope will help us meet the needs of
an even broader range of patients living with hepatitis C."
The ENDURANCE and EXPEDITION studies are part of AbbVie's Phase
3 HCV pipeline program and will recruit approximately 1,600
patients globally, from over 250 study sites and in 27 countries.
The primary efficacy endpoint of all six studies is rate of
sustained virologic response at 12 weeks post-treatment
(SVR12).
The four ENDURANCE studies evaluate AbbVie's investigational
regimen in patients without cirrhosis for up to 12 weeks.
ENDURANCE-1 compares SVR in GT1 chronic HCV infected patients who
received ABT-493/ABT-530 treatment durations of 12 weeks and as
short as eight weeks. ENDURANCE-2 evaluates AbbVie's
investigational regimen versus placebo in GT2 chronic HCV infected
patients. ENDURANCE-3 compares AbbVie's investigational regimen
with sofosbuvir/daclatasvir in treatment-naïve patients with GT3
chronic HCV infection. ENDURANCE-4 evaluates GT4-6 chronic HCV
infected patients.
The EXPEDITION trials evaluate AbbVie's investigational regimen
for 12 weeks in difficult to treat patient populations with chronic
HCV infection. EXPEDITION-1 evaluates AbbVie's investigational
regimen in GT1, 2, 4-6 chronic HCV infected patients with
compensated cirrhosis (Child-Pugh A). EXPEDITION-4 evaluates GT1-6
chronic HCV infected patients with severe renal impairment and
end-stage renal disease, with or without compensated
cirrhosis.
More information on the studies is available at
www.clinicaltrials.gov (NCT02604017, NCT02640482, NCT02640157,
NCT02636595, NCT02642432, NCT02651194).
About AbbVie's HCV Clinical Development
Program
AbbVie's HCV clinical development
program is intended to advance scientific knowledge and the
clinical care of people with chronic HCV infection by investigating
pan-genotypic (genotypes 1-6), all-oral, ribavirin-free, once-daily
treatment for 12 weeks, including eight week duration
in genotype 1 patients. AbbVie's investigational regimen
includes 300 mg ABT-493, an NS3/4A protease inhibitor, and 120 mg
ABT-530, an NS5A inhibitor.
ABT-493 was discovered during the ongoing collaboration between
AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease
inhibitors and regimens that include protease inhibitors.
About AbbVie
AbbVie is a global, research-based
biopharmaceutical company formed in 2013 following separation from
Abbott Laboratories. The company's mission is to use its expertise,
dedicated people and unique approach to innovation to develop and
market advanced therapies that address some of the world's most
complex and serious diseases. Together with its wholly-owned
subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people
worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com. Follow @abbvie on Twitter
or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
Some statements in this
news release may be forward-looking statements for purposes of the
Private Securities Litigation Reform Act of 1995. The words
"believe," "expect," "anticipate," "project" and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements
are subject to risks and uncertainties that may cause actual
results to differ materially from those indicated in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, difficulties inherent in the
research and development process, adverse litigation or government
action, and changes to laws and regulations applicable to our
industry. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," in
AbbVie's 2014 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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SOURCE AbbVie