ACH-126,443 (Beta-L-Fd4C)

liver411

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   Source:  Virus Weekly, April 2, 2002 p11.
                                                                              
    Title:  Phase II study of lead product candidate in hepatitis B patients
            initiated.(Brief Article)
                                                                              
Subjects:  Pharmaceutical industry - Product development
            Hepatitis B - Drug therapy
Companies:  Achillion Pharmaceuticals Inc. - Product development
Locations:  United States
SIC code:  2834
                                                                              
Electronic Collection:  A84267466
                   RN:  A84267466
                                                                              

Full Text COPYRIGHT 2002 NewsRX

2002 APR 2 - (NewsRx.com & NewsRx.net) -- Achillion Pharmaceuticals, a
privately held pharmaceutical company focused on the discovery, development and commercialization of innovative anti-infective agents, announced the commencement of a phase II clinical study with the company's lead product candidate, ACH-126,443 (Beta-L-Fd4C) in patients with chronic hepatitis B infection.

This phase II study (Study 443-003) will help identify the optimal dose of
ACH-126,443 to treat patients chronically infected with hepatitis B virus
(HBV), defined as the dose, which most effectively suppresses hepatitis B, DNA levels (viral load) while providing the best safety profile. This double-blind study will evaluate several doses of ACH-126,443 administered once a day to patients with chronic HBV infection, compared with lamivudine (3TC), and placebo. The 443-003 study will be conducted in multiple centers across
central and eastern Europe under Achillion's investigational new drug (IND)
application filed with the U.S. Food and Drug Administration.

"In 2 years from the launch of Achillion, we have advanced ACH-126,443 from
early preclinical testing into phase II efficacy trials. This rapid entry into
clinical development underscores the value of the experience of our team to
deliver major milestones successfully," said William G. Rice, Achillion's
chief executive officer. "Chronic hepatitis B infection is a silent epidemic
with an enormous need for additional and superior therapeutics. With existing treatments, the medical needs of patients are often not met due to adverse side effects or loss of efficacy because of viral resistance."

"The preclinical data on ACH-126,443 indicate potency against HBV strains that
are both sensitive and resistant to lamivudine, the only currently approved
oral anti-HBV drug," commented Lisa M. Dunkle, MD, senior vice president of
drug development for Achillion. "Our previous clinical studies have
demonstrated very promising safety and antiviral activity of the compound. We look forward to the data from this current study to provide more definitive information regarding the safety and efficacy of several doses of
ACH-126,443."

This article was prepared by Virus Weekly editors from staff and other
reports.
                                                                              
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