Achillion Pharmaceuticals Starts Phase 1b/2 Study in Hepatitis B Patients

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Achillion Pharmaceuticals Starts Phase 1b/2 Study in Hepatitis B Patients

NewsEdge Corporation -

Achillion Pharmaceuticals, a privately held pharmaceutical company focused

on the discovery, development and commercialization of innovative

anti-infective agents, today announced it has begun a Phase 1b/2 clinical

study of Achillion's lead compound ACH-126,443 (beta-LFd4C) for the

treatment of chronic hepatitis B (HBV) infection.

Achillion will conduct the double-blind study in multiple centers in the

U.S. and Canada. The study will examine multiple doses of ACH-126,443

administered once a day for two weeks to approximately 36 patients with

chronic hepatitis B infection. The study is designed to evaluate the safety

and pharmacologic characteristics, termed pharmacokinetics, of ACH-126,443

compared with a control, as well as to determine optimal doses to achieve

antiviral activity. Achillion recently completed a Phase 1 study of

ACH-126,443 that evaluated single doses of the compound and a control in

healthy volunteers. Results from this study indicate that the compound

possesses attractive safety and pharmacokinetic characteristics that warrant

continued development.

" We continue to advance the clinical development of ACH-126,443 by designing

this second clinical trial to evaluate a range of doses of the compound in

HBV patients in multiple centers throughout the U.S. and Canada, " commented

M. Dunkle, M.D., Senior Vice President of Drug Development for

Achillion. " Patients with chronic HBV infection represent an underserved

population in which the virus often develops resistance to the few treatment

options currently on the market. In the laboratory, ACH-126,443 has shown

greater potency against HBV than marketed drugs, and we look forward to

evaluating its antiviral effects in patients. "

Chronic HBV infection affects more than 350 million individuals worldwide

and is a common cause of liver damage and liver cancer. ACH-126,443 is an

orally administered antiviral agent with potent in vitro activity against

HBV and the Human Immunodeficiency Virus (HIV). ACH-126,443 is an

L-nucleoside, which acts to inhibit replication of HBV inside human cells.

Preclinical studies indicate that the drug candidate may offer sufficient

potency to combat drug resistance in HBV and HIV.

Achillion is a privately held pharmaceutical company dedicated to the

discovery and commercial development of innovative small molecule

anti-infective agents. The Company's broad drug development pipeline focuses

on antiviral drugs to treat diseases caused by hepatitis B and C viruses

(HBV and HCV), human immunodeficiency virus (HIV) and herpes viruses.

Achillion's potent drug discovery engine embodies both a conventional

medicinal chemistry approach directed at classical anti-infective molecular

targets and its breakthrough Zinc Finger Targeting (ZFT) drug discovery

technology.

This news release contains certain forward-looking statements that involve

risks and uncertainties. Such statements are only predictions and the

company's actual results may differ materially from those anticipated in

these forward-looking statements. Factors that may cause such differences

include the risk that products that appeared promising in early research and

clinical trials do not demonstrate safety or efficacy in larger-scale

clinical trials and the risk that the company will not obtain approval to

market its products.

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SOURCE Achillion Pharmaceuticals, Inc

CONTACT: Amy Enders of Achillion Pharmaceuticals, Inc, +1-203-401-3135; or

Rhonda Chiger of Rx Communications Group, LLC, +1-917-322-2659, for

Achillion Pharmaceuticals, Inc

Web site: http://www.achillion.com