ACHILLION INITIATES PHASE 2 STUDY OF HEPATITIS B TREATMENT.
This phase 2 study (Study 443-003) will help identify the optimal dose of ACH-126,443 to treat chronic Hepatitis B virus (HBV) infection, 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 Investigation New Drug application (IND) filed with the US Food and Drug Administration.
"In two years from the launch of Achillion, we have advanced ACH-126,443 from early pre-clinical testing into Phase 2 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 CEO. "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 pre-clinical 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."
ACH-126,443 is an L-nucleoside antiviral agent administered orally once daily that has demonstrated in vitro activity against both wild-type and lamivudine-resistant strains of HBV. Clinical studies are planned in 2002 to evaluate the efficacy of the agent in patients with lamivudine-resistant strains of HBV. Chronic HBV infection is a life-threatening disease that affects more than 350 million individuals worldwide. It is a common cause of liver damage and the leading cause of liver cancer. The World Health Organization lists chronic HBV as the ninth leading cause of death worldwide.
Pre-clinical studies have also demonstrated that ACH-126,443 effectively inhibits HIV, including lamivudine-resistant and multi-drug resistant strains. Achillion is also conducting studies to evaluate ACH-126,443 in patients with HIV infection. Over 36 million people worldwide were estimated by the National Institutes of Health to be living with HIV/AIDS at the end of 2000, with approximately 5.3 million new infections having occurred in 2000. Through 2000, the HIV/AIDS epidemic had resulted in over 20 million deaths worldwide.
Achillion is a privately held pharmaceutical company focused on the discovery, development and commercialization of innovative small molecule drugs that combat drug resistance in infectious diseases, with a particular emphasis on antiviral drugs to treat diseases caused by hepatitis B and C viruses (HBV and HCV), HIV and herpes viruses. Achillion's drug development pipeline is led by the product candidate, ACH-126,443 (Beta-L-Fd4C), which is currently in human clinical trials for the treatment of chronic hepatitis B and HIV infections. Achillion's drug discovery expertise embodies both a conventional medicinal chemistry approach directed at classic anti-infective molecular targets, and its novel Zinc Finger Targeting (ZFT) drug discovery technology developing small molecules that target zinc finger motifs unique to particular pathogens.
For more information, call 203-401-3135.
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|Date:||Apr 1, 2002|
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