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ACHN-Commences Phase I for ACH-1625, an HCV PI

http://finance.yahoo.com/news/Achillion-Announces-pz-835734835.html?x=0&.v=1

NEW HAVEN, Conn., June 29, 2009 (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 begun dosing in a Phase I clinical trial of ACH-1625, a protease inhibitor for the treatment of hepatitis C virus (HCV) infection.

The Phase I clinical trial is a randomized, double-blind, placebo-controlled trial to investigate the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-1625 after single and multiple ascending oral doses in healthy volunteers, and oral ascending repeat doses in subjects with hepatitis C infection. The trial will take place in Europe and is designed to enroll 54 subjects including both healthy volunteers and HCV-infected patients. Data from the trial are anticipated to be announced later this year.

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.

"This first-in-human clinical trial will be instrumental in establishing the safety profile of ACH-1625 in humans," stated Elizabeth A. Olek, D.O., Vice President and Chief Medical Officer of Achillion. "Importantly, it will also provide Achillion with preliminary efficacy data and important dose selection information for subsequent Phase II trials. We believe ACH-1625 has the potential to offer a convenient dosing schedule and an improved safety and tolerability profile compared to currently available treatments for HCV-infected patients."

"We are very excited to take ACH-1625 into the clinic to test the compound's safety and efficacy in humans," said Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "With its potency and safety profile in preclinical studies, and its potential for once-daily dosing, we are eager to advance what we hope will be a best-in-class candidate."

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 has demonstrated potency, unique pharmacokinetic properties and a safe in vivo profile even at very high doses.

With its rapid and extensive partitioning to the liver, as well as high liver/plasma ratios demonstrated in vivo, Achillion believes that ACH-1625 can be dosed on a convenient schedule at a relatively low dosage. 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. High safety margins have been established in both single ascending dose and repeat dose studies in vivo. Overall, Achillion believes the compound is well tolerated with minimal side effects.