- ePoster presented today at the EASL / AASLD
Special Conference: New Perspectives in Hepatitis C Virus Infection
– The Roadmap For Cure -
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
announced that updated interim results were presented today in an
ePoster describing a phase 2 study being conducted by Alios
BioPharma Inc., part of the Janssen Pharmaceutical Companies
(Janssen) at the European Association for the Study of the Liver
(EASL) Special Conference in Paris, France.
These results, updated to include expanded
safety and efficacy data, were presented in the ePoster entitled
"Short duration treatment with AL-335 and odalasvir (ODV), with or
without simeprevir (SMV), in treatment-naïve patients with
hepatitis C virus (HCV) genotype (GT) 1 infection." It reports that
100 percent of patients receiving treatment for as short as six
weeks with a triple combination of once-daily (QD) AL-335 800mg and
simeprevir (SMV) 75mg with 50mg every other day (QOD) of ODV
achieved a sustained viral response 12 weeks after the completion
of treatment (SVR12).
“Odalasvir has continued to show that it has the
potential to shorten the treatment duration to as little as six
weeks in combination with other direct acting antivirals for the
treatment of HCV,” commented Dr. Milind Deshpande, president and
chief executive officer of Achillion. “We now look forward to
seeing confirmation of these impressive data in Janssen’s global
development program.”
Summary of Phase 2 Study Design and
Interim Results
This study was designed to determine the safety,
pharmacokinetics, and efficacy of different dosing regimens
containing ODV and AL-335, with or without SMV, in treatment-naïve
patients with GT1 HCV infection for treatment durations of eight or
six weeks.
Of the GT1 non-cirrhotic patients that received
the triple combination of ODV, AL-335, and simeprevir 100 percent
remained HCV RNA undetectable at SVR12 and all patients in cohort 1
achieved SVR24 (i.e., cohorts 1, 3, and 4; N=60, 20/cohort). Cohort
1 evaluated the triple combination of ODV (50mg QD), AL-335 (400mg
QD) and simeprevir (100mg QD) for eight weeks, while cohorts 3
& 4 assessed ODV (50 mg QOD), AL-335 (800 mg QD), and SMV (75
mg QD) for eight and six weeks, respectively. In cohort 2, which
assessed the dual combination of ODV (50mg QOD) and AL-335 (800mg
QD) for eight weeks, 90 percent of subjects achieved SVR12 (N=20).
In all of these cohorts, the dosing regimens
were generally well-tolerated. The majority of adverse events (AEs)
were mild and the most commonly reported events were headache,
fatigue, and upper respiratory tract infection. As previously
reported in the abstract, there was one serious adverse event (SAE)
in cohort 1 that resulted in premature discontinuation of all study
drugs. This consisted of a Mobitz Type 1 2nd degree
atrioventricular block and was deemed probably related to ODV and
possibly related to AL-335 and simeprevir. The event was not
associated with clinical or echocardiographic abnormalities, did
not require any therapeutic intervention, resolved following
treatment discontinuation, and the patient went on to achieve
SVR24. No clinically significant laboratory, echocardiography, or
ECG abnormalities (except the SAE) were reported.
Ongoing Phase 2 Triple Combination
Development Program
The interim results from this phase 2 study
confirmed the treatment duration and dose for each component of the
triple combination (i.e., once-daily ODV 25mg, AL-335 800mg, and
SMV 75mg for treatment durations of six and eight weeks). The
development program will include a multi-center, randomized,
open-label study that will enroll treatment-naïve and
treatment-experienced non-cirrhotic patients chronically infected
with hepatitis C virus genotypes 1, 2, 4, 5, and 6. In
addition, the ongoing phase 2a study is assessing the triple
combination in patients with or without compensated cirrhosis, and
with HCV genotype 3 infection.
Further information on clinical studies can be found at
www.clinicaltrials.gov. Study identifier: NCT02765490.
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
potential therapeutic benefit of odalasvir in combination with
other direct acting antivirals for the treatment of HCV; the
Company’s expected plans, timing, data readouts and results from
ongoing and planned clinical trials of 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: 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; 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 Achillion’s HCV assets under
the exclusive worldwide license Achillion 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
Achillion’s 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 June 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
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
Media:
Liz Power
Achillion Pharmaceuticals, Inc.
Tel: (203) 752-5509
lpower@achillion.com
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