Achillion Presents Detailed Clinical Results on ACH-3102 and ACH-3422 at the International Liver Congress
April 25 2015 - 9:30AM
- Two late breaker presentations detail
previously announced 100% SVR12 in Phase 2 trial evaluating 6- or
8-weeks of treatment with ACH-3102 and sofosbuvir in genotype 1 HCV
patients and Phase 1 proof-of-concept results with ACH-3422 -
- Clinical virology presentation continues to
support improved barrier to resistance with ACH-3102 -
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
today presented two late breaker posters at the 50th Annual Meeting
of the European Association for the Study of the Liver (EASL)
during The International Liver Congress 2015.
"We believe that the ability to achieve 100% SVR12 after
six-weeks of treatment with ACH-3102 and sofosbuvir supports the
potential for our proprietary doublet regimen to reduce treatment
duration for HCV patients," commented Milind Deshpande, Ph.D.,
President and Chief Executive Officer of Achillion. "We are also
very pleased with the robust Phase 1 proof-of-concept data reported
on ACH-3422, our proprietary NS5B nucleotide polymerase inhibitor,
and the clinical virology presentation that continues to support
the differentiated higher barrier to resistance for ACH-3102."
Data highlights from all of the presentations include:
LP06: Sustained virologic response after
ACH-3102 and sofosbuvir treatment for 8 or 6 weeks: A phase 2
"proxy" study ACH102-017. ePoster Presentation, April 25, 3:30 pm
CET, Hall B ePoster Area. Lead Author: Edward Gane.
- As previously reported, 100% of patients achieved SVR12 after
six- (n=12) or eight-weeks (n=12) of treatment in this ongoing
interferon-free, ribavirin-free study evaluating the efficacy,
safety, and tolerability of 50 mg of ACH-3102 and 400 mg of
sofosbuvir, a marketed nucleotide polymerase inhibitor, in
treatment-naïve genotype 1 HCV-infected patients.
- This represents the first study to report 100% SVR12 in
patients with chronic GT-1 HCV infection using a two-drug
combination for 6 weeks.
- Complete virologic responses were seen in all patients,
including those who were considered harder to treat than others
(i.e. GT-1a, non-CC and VL > 6 million IU/mL).
- The combination of ACH-3102 with sofosbuvir was well tolerated,
with no treatment discontinuations, a low incidence of AEs, and no
reported significant AEs or SAEs during the treatment and follow-up
periods.
- The present study provides support for future studies which
will explore the use of ACH-3102 in sofosbuvir-sparing regimens
with short-treatment durations.
- In parallel, further studies will explore the combination of
ACH-3102 and ACH-3422 (with and without sovaprevir, an NS3 protease
inhibitor) in interferon- and ribavirin-free regimens with short
treatment durations across different patient populations.
LP27: Gane, E., et al. ACH-3422, a novel
nucleotide prodrug inhibitor of HCV NS5B polymerase. ePoster
Presentation, April 25, 3:30 pm CET, Hall B ePoster Area. Lead
Author: Edward Gane.
- As previously announced, ACH-3422 achieved dose-related
virologic responses in GT-1 HCV-infected patients. In the six
patients who received 700 mg once daily for 14 days, mean maximal
reduction from baseline was 4.6 log10, including three patients
with target not detected.
- In all healthy volunteers and patients infected with HCV who
received active treatment through 700 mg once daily, ACH-3422 was
well-tolerated with no treatment-related serious adverse events,
adverse event-related discontinuations, or clinically significant
laboratory or ECG abnormalities.
- These results support further investigation of ACH-3422 with
ACH-3102, a potent NS5A inhibitor, with or without the NS3/4A
protease inhibitor sovaprevir, for the treatment of different
patient populations with chronic HCV infection.
P0805: Achievement of SVR12 despite the
presence of HCV variants resistant to first generation NS5A
inhibitors in genotype-1 hepatitis C patients after 8-week therapy
of ACH-3102 in combination with sofosbuvir. ePoster Presentation,
April 24, 10:00 am CET, Hall B ePoster Area. Lead Author: Wengang
Yang.
- Dominant NS5A variants found at baseline conferred significant
resistance to ledipasvir and daclatasvir but not to ACH-3102,
highlighting the mechanism underlying the improved clinical
efficacy of ACH-3102.
- The clinical efficacy of ACH-3102 is also supported by its
greater potency in vitro against a spectrum of GT-1a and -1b NS5A
mutants as compared to the first generation of NS5A
inhibitors.
- These data support further clinical exploration of
ACH-3102.
About HCV
The hepatitis C virus is the most common cause of viral
hepatitis, which is an inflammation of the liver. It is currently
estimated that more than 150 million people are infected with HCV
worldwide including more than 5 million people in the United
States. Three-fourths 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.
About Achillion Pharmaceuticals
Achillion is seeking to apply its expertise in biology and
structure-guided design and a deep understanding of patient and
clinician needs to develop innovative treatment solutions aimed at
improving patients' lives. The Company believes that its scientific
excellence, integrated capabilities and experienced team position
it to successfully achieve its goal of advancing new products along
the entire continuum from the bench to the patient. Achillion's
pipeline is currently focused on small molecule therapeutics for
infectious disease and complement-related diseases.
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, including
without limitation statements with respect to: the potential to
create shorter treatments for HCV patients and the potential
therapeutic and other benefits of ACH-3422 and ACH-3102. Achillion
may use words such as "expect," "anticipate," "project," "intend,"
"plan," "aim," "believe," "seek," " estimate," "can," "focus,"
"will," and "may" and similar expressions to identify such
forward-looking statements. 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: demonstrate in any current and
future clinical trials the requisite safety, efficacy and
combinability of its drug candidates; advance the preclinical and
clinical development of its drug candidates, including ACH-3102,
ACH-3422, and sovaprevir, under the timelines it projects in
current and future clinical trials; obtain and maintain necessary
regulatory approvals; obtain and maintain patent protection for its
drug candidates and the freedom to operate under third party
intellectual property; establish commercial manufacturing
arrangements; identify, enter into and maintain collaboration
agreements with appropriate third-parties; compete successfully
with other companies that are seeking to develop improved therapies
for the treatment of HCV; manage expenses; manage litigation; raise
the substantial additional capital needed to achieve its business
objectives; and successfully execute on its business strategies.
These and other risks are described in the reports filed by
Achillion with the U.S. Securities and Exchange Commission,
including its Annual Report on Form 10-K for the fiscal year ended
December 31, 2014, 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.
CONTACT: Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
gschulman@achillion.com
Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com
Investors:
Clayton Robertson
The Trout Group, LLC
Tel. (646) 378-2964
crobertson@troutgroup.com
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