Achillion Announces Initiation of Phase 1 Trial of ACH-2928 for the Treatment of Hepatitis C
First-in-Human Trial to Evaluate Safety and Tolerability of First Generation NS5A Inhibitor in Both Healthy Subjects and Genotype 1 HCV-Infected Patients
NEW HAVEN, Conn., Jul 11, 2011 (GlobeNewswire via COMTEX) -- Achillion Pharmaceuticals, Inc. /quotes/zigman/100395/quotes/nls/achn ACHN -1.57% , a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that it has begun dosing in a Phase 1 clinical trial of ACH-2928, a NS5A inhibitor, being developed for the treatment of chronic hepatitis C virus (HCV) infection.
The Phase 1 clinical study is a randomized, double-blind, placebo-controlled trial to investigate the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-2928. The trial consists of three segments, including assessment of single ascending oral doses in healthy volunteers, a 5-day multiple ascending doses segment in healthy volunteers, and evaluation of 3 days of oral ascending repeat doses in subjects with genotype 1 hepatitis C infection. The trial will take place in the United States and is designed to enroll approximately 48 healthy volunteers and 20 HCV genotype 1 treatment naive patients.
"This clinical trial with our first NS5A inhibitor aims to provide us with a substantial amount of information regarding the safety and tolerability of ACH-2928, as well as insight into its potential activity against HCV genotypes 1a and 1b," commented Elizabeth A. Olek, D.O., Vice President and Chief Medical Officer of Achillion.
"Initiating clinical development with ACH-2928, the first compound advanced from our NS5A inhibitor program, represents an important step in our ultimate strategy of becoming a leader in the development of HCV combination therapies involving our protease and NS5A inhibitors," said Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "Over the next few quarters, we plan to achieve human proof-of-concept on ACH-2928 and to advance an additional NS5A inhibitor into clinical development. Furthermore, we intend to obtain additional clinical results from our protease inhibitor programs including 12-week EVR results from the Phase 2a trial with ACH-1625 and to establish clinical proof-of-concept on ACH-2684, our pan-genotypic agent being evaluated in Phase 1."
About NS5A Inhibitors and ACH-2928
The NS5A protein is a clinically validated target that serves multiple functions at various stages of the HCV life cycle including involvement in virion production, interaction with host proteins and association with interferon-resistance. Achillion's NS5A inhibitors, including ACH-2928, demonstrate potent activity against all HCV genotypes and demonstrate in preclinical studies additive to synergistic activity when combined with NS3 protease inhibitors, NS5B polymerase inhibitors, interferon and ribavirin. In preclinical studies, ACH-2928 has demonstrated excellent potency, in the pico-molar range, against HCV RNA replication, along with good pharmacokinetic and safety profiles.
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 170 million people are infected with HCV worldwide and The American Association of Liver Disease estimates that up to 80% of individuals become chronically infected following exposure to the virus. If left untreated, chronic hepatitis can lead to permanent liver damage, which can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration.
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
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 factors, including statements with respect to the potency, safety and other characteristics of Achillion's NS5A inhibitors, including ACH-2928, which may not be duplicated in clinical studies, and Achillion's expectations regarding results, timing and duration of clinical trials and reporting of results from clinical trials of ACH-1625, ACH-2684 and Achillion's NS5A inhibitors, including ACH-2928. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are Achillion's ability to complete the development of its drug candidates under the timelines it anticipates in current and future clinical trials; to obtain patent protection for its drug candidates, and the freedom to operate under third party intellectual property; to establish commercial manufacturing arrangements and to identify, enter into and maintain collaboration agreements with appropriate third-parties; and to raise the capital needed to achieve its business objectives. 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, 2010 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 obligation to update any forward-looking statement, except as required by applicable law.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Achillion Pharmaceuticals, Inc.
CONTACT: Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com
Media:
Christin Culotta Miller
Ogilvy PR
Tel. (646) 229-5178
christin.miller@ogilvypr.com
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