- ePoster presented today at the EASL / AASLD Special Conference: New Perspectives in Hepatitis C Virus
Infection – The Roadmap For Cure -
- Ongoing Phase 2 development focusing on triple combination for treatment durations as short as six weeks
for broad HCV population –
PARIS, Sept. 23, 2016 (GLOBE NEWSWIRE) -- 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
