- New data released today in abstract for
upcoming EASL / AASLD Special Conference: New Perspectives in
Hepatitis C Virus Infection – The Roadmap For Cure -
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
announced today that new interim results from a phase 2a study
being conducted by Alios BioPharma, Inc., part of the Janssen
Pharmaceutical Companies (Janssen), were published as part of the
abstracts released for the upcoming European Association for the
Study of the Liver (EASL) Special Conference, September 23 - 24,
2016, in Paris, France.
This ongoing phase 2a study was designed to
confirm the required dose and treatment duration for an all-oral
combination regimen containing odalasvir (ODV) and AL-335 with or
without simeprevir (SMV) for durations of eight or six weeks of
treatment in treatment-naïve patients with genotype 1 (GT1) chronic
hepatitis C virus (HCV) infection.
“We are delighted by the significant progress
Janssen has made in advancing the all-oral, short-duration
treatment regimen of odalasvir, AL-335 and simeprevir and are
impressed with the Phase 2a study results being presented. Based on
these interim results, Janssen plans to advance a phase 2b program
for the triple combination to further understand the potential of
this 3DAA drug combination to shorten the duration of treatment for
patients suffering from HCV,” commented Dr. Milind Deshpande,
President and Chief Executive Officer of Achillion. “Despite recent
therapeutic advances, we believe there remains a significant unmet
need in addressing the global burden of hepatitis C virus in those
living with the disease.”
Data included in the abstract were as of the
time of submission in July 2016. Updated results, including
sustained viral response 12 weeks after completion of therapy
(SVR12) for all cohorts, are scheduled to be presented on Friday,
September 23, 2016, in an 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." Interim results from
cohorts 1-4, summarized in the table below, showed that the triple
combination regimen was highly effective and well tolerated in
non-cirrhotic patients with GT1 HCV.
Table 1: Interim Phase 2a Results for Cohorts 1
– 4
Cohort # |
Dose |
DosingDuration
(weeks) |
Number (%) withundetectable*
HCV RNA (EOT or SVR) |
AL-335 (mg QD) |
ODV (mg) |
SMV (mg QD) |
1 |
400 |
50 QD |
100 |
8 |
20/20 (100%), SVR24 |
2 |
800 |
50 QOD |
-- |
8 |
18/20 (90%), SVR12 |
3 |
800 |
50 QOD |
75 |
8 |
20/20 (100%), SVR4 |
4 |
800 |
50 QOD |
75 |
6 |
20/20 (100%), EOT |
*Or below the limit of quantitation (N=2; Cohort
4 only)EOT: end of treatment; QD: every day; QOD: every other day;
RNA: ribonucleic acid
Summary of Phase 2a Study Design and
Interim Results
This phase 2a study was designed to determine
the pharmacokinetics, efficacy and safety of ODV and AL-335 with or
without SMV, in treatment naïve patients with GT1 or 3 HCV
infection for treatment durations of eight weeks or less.
Of the 20 patients treated in cohort 1, who
received the triple combination of odalasvir (50mg QD), AL-335
(400mg QD) and simeprevir (100mg QD) for eight weeks (triplet, 8
weeks), 100 percent remained HCV RNA undetectable 24 weeks after
completing therapy (SVR24). Additional patients were subsequently
enrolled into two further cohorts (3 & 4), where they received
adjusted doses of the same triplet combination for either eight or
six weeks. In cohort 3 all were HCV RNA negative and remained HCV
RNA undetectable 4 weeks after completing therapy (SVR4) and in
cohort 4 all were HCV RNA negative (N=18) or below the limit of
quantitation (N=2) at end of treatment. Of the 20 patients treated
in cohort 2, who received the dual combination of odalasvir (50mg
QOD) and AL-335 (800mg QD) for eight weeks (doublet, 8 weeks), 90
percent remained HCV RNA undetectable twelve weeks after completing
therapy (SVR12).
All-oral combination regimens, containing
odalasvir, AL-335 with or without simeprevir were generally safe
and well tolerated. The majority of adverse events (AEs) were
mild, most commonly headache, fatigue, and upper respiratory tract
infection. In cohort 1, there was a single serious adverse event
(Mobitz Type 1 2nd degree atrioventricular block), which was
attributed to treatment. This ECG abnormality was not associated
with clinical or echocardiographic abnormalities, and resolved
following treatment discontinuation. No clinically significant
laboratory abnormalities were observed.
Ongoing Phase 2 Development
Program
Based upon the interim results from the phase 2a
study, which confirmed the required dose for each component and the
treatment duration, the triple combination is being advanced into a
phase 2b program consisting of once daily odalasvir 25mg, AL-335
800mg, and simeprevir 75mg. The development program will
include two multi-center, randomized, open-label studies that will
enroll treatment-naive and treatment-experienced non-cirrhotic
patients chronically infected with hepatitis C virus genotypes 1,
2, 4, 5, and 6. These studies will be complemented by an
expansion of the ongoing phase 2a study focusing on patients with
or without compensated cirrhosis and on patients with HCV genotype
2 and 3 infection. The results from the phase 2 program will guide
further development.
Further information on this study can be found at
www.clinicaltrials.gov. Study identifier: CT02765490.
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 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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