Achillion Announces Initiation of Patient Dosing by Janssen in a Global, Short Treatment-Duration Phase 2b Study of JNJ-4178 ...
30 November 2016 - 10:05PM
- Janssen initiates dosing of patients in
OMEGA-1: Phase 2b study evaluating six- and eight-week treatment
durations with JNJ-4178, a 3DAA combination of odalasvir,
simeprevir, and AL-335, for the treatment of chronic HCV -
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
today announced the start of patient dosing in a global Phase 2b
open-label OMEGA-1 study of JNJ-4178, a 3DAA combination of
odalasvir, simeprevir, and AL-335, has been initiated by Janssen
Research & Development, LLC., part of the Janssen
Pharmaceutical Companies of Johnson & Johnson (Janssen), in
treatment-naive and treatment-experienced patients with chronic
hepatitis C virus infection (HCV) without cirrhosis.
This large, international, multi-center study is
expected to enroll approximately 300 HCV patients, and is part of
Janssen’s global development program for JNJ-4178. Clinical trial
sites are located in Europe, North America, and Asia.
The objectives of OMEGA-1 are to investigate the
efficacy, safety and pharmacokinetics of JNJ-4178 (odalasvir (25mg
QD), simeprevir (75mg QD), and AL-335 (800mg QD)) in
treatment-naive and treatment-experienced non-cirrhotic patients
with chronic hepatitis C virus genotype 1, 2, 4, 5, and 6
infection. Patients in the study will receive the triple
combination once daily for either 6 or 8 weeks. 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 2a study (‘604’ study) is
assessing JNJ-4178 in patients with or without compensated
cirrhosis.
Further information on these trials can be found
on www.clinicaltrials.gov. Study identifiers NCT02765490 and
NCT02569710.
About HCV
Globally, HCV infection is a leading cause of
liver disease and liver related mortality. It is currently
estimated that more than 150 million people are infected with HCV
worldwide including approximately 3 million people in the United
States. Three-quarters of the HCV patient population is
undiagnosed; it is a silent epidemic and a major global health
threat. Chronic hepatitis, if left untreated, can lead to permanent
liver damage that can result in the development of liver cancer,
liver failure or death. Despite available treatments, there remains
a significant unmet need for many patients infected with HCV.
About Achillion
Pharmaceuticals
Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) is
a science-driven, patient-focused company seeking to leverage its
strengths across the continuum from discovery to commercialization
in its goal of providing better treatments for people with serious
diseases. The company employs a highly-disciplined discovery and
development approach that has allowed it to pursue best-in-class
oral antiviral therapy for chronic hepatitis C (HCV) and build a
platform of potent and specific complement inhibitors. Achillion is
rapidly advancing its efforts to become a fully-integrated
pharmaceutical company with a goal of bringing life-saving
medicines to patients with rare diseases. More information is
available at http://www.achillion.com
Cautionary Note Regarding
Forward-Looking Statements
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that are subject to risks, uncertainties and
other important factors that could cause actual results to differ
materially from those indicated by such forward-looking statements.
Achillion may use words such as “expect,” “anticipate,” “project,”
“intend,” “plan,” “aim,” “believe,” “seek,” “ estimate,” “can,”
“focus,” “will,” “look forward,” “goal,” and “may” and similar
expressions to identify such forward-looking statements. These
forward-looking statements also include statements about: the
Company’s expected plans, timing, data readouts and results from
ongoing and planned clinical trials of both ACH-4471 and HCV
development candidates being advanced by Janssen under the
Company’s collaboration with Janssen; and statements concerning the
Company’s strategic goals, milestone plans, and prospects. Among
the important factors that could cause actual results to differ
materially from those indicated by such forward-looking statements
are risks relating to, among other things Achillion’s ability to:
advance the preclinical and clinical development of its complement
factor D inhibitors under the timelines it projects in current and
future preclinical studies and clinical trials; obtain and maintain
patent protection for its drug candidates and the freedom to
operate under third party intellectual property; demonstrate in any
current and future clinical trials the requisite safety, efficacy
and combinability of its drug candidates; obtain and maintain
necessary regulatory approvals; establish commercial manufacturing
arrangements; identify, enter into and maintain collaboration
agreements with third-parties, including the current collaboration
with Janssen; compete successfully in the markets in which it seeks
to develop and commercialize its product candidates and future
products; manage expenses; manage litigation; raise the substantial
additional capital needed to achieve its business objectives; and
successfully execute on its business strategies. Furthermore,
because Janssen is solely responsible for the development and
commercialization of our HCV assets under the exclusive worldwide
license we granted to it and has the deciding vote on all
collaboration matters, Janssen generally has full discretion over
all development plans and strategies and may not advance the HCV
programs in the time frames Achillion or Janssen projects, or at
all, including with regard to the current and planned phase 2a and
phase 2b combination trials that include our licensed drug
candidates. These and other risks are described in the reports
filed by Achillion with the U.S. Securities and Exchange
Commission, including its Quarterly Report on Form 10-Q for the
fiscal quarter ended September 30, 2016, and its subsequent SEC
filings.
In addition, any forward-looking statement in
this press release represents Achillion’s views only as of the date
of this press release and should not be relied upon as representing
its views as of any subsequent date. Achillion disclaims any duty
to update any forward-looking statement, except as required by
applicable law.
Investors:
Glenn Schulman, PharmD, MPH
Executive Director, Investor Relations
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
Media:
Liz Power
Senior Director, Public Relations
Achillion Pharmaceuticals, Inc.
Tel: (203) 752-5509
lpower@achillion.com
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