[Nice to see ACHN running pre-clinical DDI studies on 1625 and 2928 given the recent IDIX DDI news. I'm curious as to why no mention of doing studies on a 2684/2928 combo given that this would be a pan-genotypic combo, but this is presumably because both compounds are yet to enter the clinic whereas 1625 is at least ready for Phase 2.]
Achillion to Present Multiple Posters at AASLD's The Liver Meeting 2010
ACH-1625 Protease Inhibitor Abstract Accepted as Late Breaking Poster
Growing Data Set Underscores Company's Significant HCV Franchise
NEW HAVEN, Conn., Sept. 15, 2010 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN - News), a leader in the discovery and development of treatments for the most challenging infectious diseases, today announced that its abstract titled "ACH-1625 Demonstrates Sustained Viral Suppression in Presence of Uncommon Drug Resistant HCV Variants: Pharmacokinetic, Pharmacodynamic and Clinical Virology Analysis of Phase I Study" has been accepted as a late breaking poster presentation at the 61st Annual Meeting of the American Association for the Study of Liver Disease (AASLD) The Liver Meeting(R) 2010 being held October 29-November 2, 2010 in Boston.
Two additional abstracts on ACH-1625 titled "In Vitro Combination Studies of ACH-1625 (HCV NS3 Protease Inhibitor) and ACH-2928 (HCV NS5A inhibitor) in Presence and Absence of Ribavirin" and "Non-Clinical Studies to Assess Drug-Drug Interaction Potential of ACH-1625, a Clinically Effective HCV NS3 Protease Inhibitor" had previously been accepted for poster presentation.
In addition, an abstract on ACH-2684 titled "HCV NS3 Protease Inhibitor with Potent Activity against Multiple Genotypes and Known Resistant Variants" was previously accepted for poster presentation.
Achillion's late breaking poster will be displayed in the Late Breaking Poster Session on Monday, November 1 at 8:00 a.m. through the end of the day's session. The balance of the Company's posters will be displayed in the HCV Therapy: Preclinical and Early Clinical Development Poster Session on Tuesday, November 2 at 7:00 a.m. through the end of the day's session.
"The Liver Meeting 2010 is noteworthy for Achillion because, for the first time, we are presenting a significant amount of clinical data in support of our expanding HCV pipeline of products. The clinical data for ACH-1625 further supports this compound's potential to be a best-in-class therapy, and our pre-clinical data elucidate the potential for powerful combination therapies with our own drug candidates," noted Michael Kishbauch, President and Chief Executive Officer
"We were especially pleased to have our data selected for a Late Breaking poster as it underscores the importance of our positive clinical data with ACH-1625 to treat HCV since only a few such submissions were chosen for Late Breaking presentation. We look forward to sharing our positive results with the clinical and scientific audience at AASLD and to advancing ACH-1625 into Phase 2 studies this month."
About American Association for the Study of Liver Diseases
AASLD is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease. AASLD was founded in 1950 by a small group of leading liver specialists to bring together those who had contributed to the field of hepatology.
AASLD has grown to an international society responsible for all aspects of hepatology, and its annual meeting, The Liver Meeting(R), has grown in attendance from 12 to over 7,000 physicians, surgeons, researchers, and allied health professionals from around the world.
Hepatology has been recognized as a discipline only in the last few decades, and AASLD played a seminal and unifying role in focusing interest on hepatological problems, as well as the founding of other hepatological societies. AASLD organized the American Liver Foundation to educate the public about liver diseases.
About ACH-1625
ACH-1625 is an HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. With its rapid and extensive partitioning to the liver, as well as high liver/plasma ratios demonstrated in preclinical studies, Achillion believes that ACH-1625 has the potential for once daily dosing. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50~1nM.
In clinical studies completed to date, subjects receiving both single and multiple ascending doses ranging from 50 mg to 2000 mg for periods up to 5 days demonstrated that ACH-1625 was well tolerated at all doses and there were no serious adverse events, no clinically significant changes in vital signs, electrocardiograms (ECGs), or laboratory evaluations. HCV-infected patients receiving doses ranging from 200 to 600 mg twice daily, and 400 to 600 mg once daily, showed mean maximal reductions in viral load ranging from of 3.81og10 to 4.25 log10. Furthermore, all patients had viral loads that remained suppressed for at least 7 days after dosing was completed, maintaining a mean reduction of more than 2.0log10 from baseline through day 12, the last day of viral load measurement in the study.
About ACH-2684
ACH-2684 is a high potency protease inhibitor with potency in the picomolar range and activity against all HCV genotypes including highly-resistant strains of the HCV virus. The potency and virology profile of ACH-2684 demonstrates that it very effectively suppresses a broad range of natural variants of the hepatitis C virus, and may be effective in prevention and treatment of emerging resistant variants. This compound also retains potent activity against all genotypes.
About ACH-2928
ACH-2928, an NS5A inhibitor with potent activity against all genotypes, is highly effective in combination with NS3 protease inhibitors, NS5B polymerase inhibitors, interferon and ribavirin. In preclinical studies ACH-2928 has demonstrated excellent potency against HCV RNA replication, as well as good pharmacokinetic and safety profiles.
About Achillion
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 -- hepatitis C, resistant bacterial infections and HIV. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000 1-203-624-7000 .
Achillion Announces Dosing of First Patient in Phase II Trial of ACH-1625 for the Treatment of Hepatitis C
NEW HAVEN, Conn., Sept. 30, 2010 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN - News), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that the Company has initiated patient dosing in a Phase II clinical trial of ACH-1625 for the treatment of hepatitis C virus (HCV) infection. ACH-1625 is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication. The drug candidate was discovered and is being advanced by Achillion.
The clinical trial is a Phase IIa, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability and antiviral activity of oral ACH-1625 in combination with pegylated interferon alfa-2a and ribavirin after 28 days of dosing and after 12 weeks of dosing in subjects with chronic hepatitis C virus genotype 1. The trial will take place in the United States and Europe and is designed to enroll approximately 120 HCV-infected patients. The 28-day and 12-week trial data are anticipated to be announced in the first and fourth quarters of 2011, respectively.
"This Phase II clinical trial will allow us to establish the most appropriate once-daily dose to use in longer-term trials, and will augment our existing safety database for ACH-1625 in humans," stated Elizabeth A. Olek, D.O., Vice President and Chief Medical Officer of Achillion. "The results will also provide important combination data for use of ACH-1625 with standard of care. We anticipate that the 28-day segment of the trial will provide us with rapid viral response (RVR) data early next year, and that the 12-week segment will provide extended viral response (cEVR) data by the end of next year."
"The initiation of Phase II dosing for ACH-1625 is a very important step in further solidifying this compound's profile as a potentially best-in-class protease inhibitor for HCV treatment," said Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "We believe ACH-1625 has the potential to provide an improved safety and tolerability profile, a more convenient dosing schedule and an extended period of viral suppression compared to currently available treatments for HCV-infected patients."
About ACH-1625
ACH-1625 is an HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. With its rapid and extensive partitioning to the liver, as well as high liver/plasma ratios demonstrated in preclinical studies, Achillion believes that ACH-1625 has the potential for once daily dosing. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50~1nM.
In clinical studies completed to date, subjects receiving both single and multiple ascending doses ranging from 50 mg to 2000 mg for periods up to 5 days demonstrated that ACH-1625 was well tolerated at all doses and there were no serious adverse events, and no clinically significant changes in vital signs, electrocardiograms (ECGs) or laboratory evaluations. HCV-infected patients receiving doses ranging from 200 to 600 mg twice daily, and 400 to 600 mg once daily, showed mean maximal reductions in viral load ranging from of 3.07 log10 to 4.25 log10. Furthermore, all patients had viral loads that remained suppressed for at least 7 days after dosing was completed, maintaining a mean reduction of more than 1log10 from baseline through day 12, the last day of viral load measurement in the study.
About HCV
The hepatitis C virus (HCV) 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. 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, injectable route of administration and high cost.
About Achillion
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 --hepatitis C, resistant bacterial infections and HIV. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000 1-203-624-7000 .
Market Data 
Markets 
AI
