Anadys Pharmaceuticals And LG Life Sciences Report Results From Completed Phase I/II Clinical Trial Of ANA380 (LB80380) For Hepatitis B
11/1/2004
Source: Anadys Pharmaceuticals, Inc.; LG Life Sciences, Ltd.
Anadys Pharmaceuticals, Inc. and LG Life Sciences, Ltd. (KOSPI: 68870) reported results from a recently completed Phase I/II clinical trial of ANA380 (LB80380), an orally available compound for the treatment of hepatitis B virus (HBV) infection, at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting yesterday in Boston.
In a presentation entitled "Phase I/II Double-Blind, Randomized, Placebo-Controlled Study of the Novel Anti-HBV Agent LB80380/ANA380 in Patients with Chronic HBV Infection," Dr. Man-Fung Yuen of the University of Hong Kong reported that ANA380 reduced viral load by an average of 3.4 log10 units, or more than 99.9 percent, in the chronically HBV-infected patients receiving doses of 60 mg or more for four weeks. The data also demonstrated that oral administration of ANA380 for 28 days was well tolerated and safe at all doses studied, although definitive conclusions regarding product safety cannot be made until the results of future clinical trials of longer duration in more patients are known.
The Phase I/II clinical trial was designed to assess the safety, pharmacokinetics and antiviral activity of ANA380 in patients chronically infected with HBV. The study was a double-blind, randomized, placebo-controlled, multiple ascending dose evaluation of ANA380 dosed once daily for 28 days at 30 mg, 60 mg, 120 mg and 240 mg. Cohorts of seven patients were randomized to treatment or placebo in a ratio of six to one at each dose level, and safety was established at each dose prior to dose escalation. Viral load reduction was greater for doses of 60 mg and above than for the 30 mg dose, with individual viral load reductions ranging from 2 to 6 log10 units in the treated patients.
Patients participating in the study were monitored for a period of 12 weeks after completing the dosing phase. Viral load in all treated patients returned to pre-treatment levels during follow-up, confirming that the viral load declines were associated with ANA380 administration.
"This compound has demonstrated substantial anti-HBV effects at all doses studied," said Dr. Yuen. "The excellent tolerability and potent activity of ANA380, which includes in vitro activity against HBV strains resistant to lamivudine, encourages additional clinical investigation."
Anadys and LG Life Sciences recently announced that the first two cohorts have completed enrollment in a new clinical trial to assess the safety and antiviral activity of ANA380 in patients with lamivudine-resistant HBV infection. Prof. Ching-Lung Lai of the University of Hong Kong is scheduled to review several investigational compounds as part of his presentation at the Therapies for Viral Hepatitis Workshop in Boston on November 3, 2004, including preliminary data from this ongoing study that appear to support the observation that ANA380 exhibits activity against lamivudine-resistant strains.
About ANA380 (LB80380)
ANA380 (LB80380) is an oral prodrug of ANA317 (LB80317), a nucleotide analog that has exhibited potent activity against HBV, including in vitro activity against HBV strains resistant to lamivudine, the current standard of treatment for patients infected with HBV. Anadys and LG Life Sciences are jointly developing ANA380 on a global basis. In April, Anadys acquired an exclusive license from LG Life Sciences for the commercialization of ANA380 in North America, Europe, Japan and the rest of the world other than China, Korea, India and countries in Southeast Asia.
About Hepatitis B
Hepatitis B virus infections are a growing global health problem that can cause both acute and chronic viral infections. Approximately 350 million people are chronically infected and have become carriers of HBV. Approximately 15 to 40 percent of these patients will develop serious consequences of infection during their lifetime, including loss of liver function, cirrhosis, and liver cancer. According to World Health Organization, around 1 million people die each year from chronic HBV or related conditions.
About Anadys
Anadys Pharmaceuticals, Inc. (http://www.anadyspharma.com/) is a biopharmaceutical company committed to advancing patient care by discovering, developing and commercializing novel small molecule, anti-infective medicines for the treatment of hepatitis C virus (HCV), hepatitis B virus (HBV) and bacterial infections. Anadys is advancing its anti-infective portfolio through the development of its two clinical programs, the isatoribine family of compounds including the oral prodrug ANA975 for the treatment of HCV, and ANA380 for the treatment of HBV. In addition, Anadys' anti-infective therapeutic platform is designed to advance a strong and continual pipeline of drug candidates into the clinic.
About LG Life Sciences
LG Life Sciences, Ltd (LGLS, http://www.lgls.co.kr/), an LG affiliate, is an R&D based biopharmaceutical company based in Seoul, Korea that discovers, develops and commercializes new medicines in anti-infectives, cancer, diabetes and other chronic diseases. In year 2003, LGLS had approximately $150 million in revenue and 1000 employees. LGLS aims to become a leading life science company by utilizing its R&D capabilities to develop global brand products such as Factive® (gemifloxacin) and by expanding its marketing presence in key Asian markets.
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, the effects of administration of ANA380 (LB80380) in HBV infected patients, including ANA380 (LB80380)'s safety profile, potency, and activity against HBV strains resistant to lamivudine, as well as expectations regarding further clinical trials of ANA380 (LB80380). Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results of LGLS and/or Anadys Pharmaceuticals to be materially different from historical results or from any results expressed or implied by such forward-looking statements. In particular, the results of initial clinical trials may not be predictive of future results, and Anadys and LGLS cannot provide any assurances that ANA380 (LB80380) will have favorable results in later clinical trials, or that ANA380 (LB80380) will receive regulatory approval. In addition, Anadys' results may be affected by competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to successfully develop and market products, difficulties or delays in its clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments involving future products and its ability to obtain additional funding to support its operations. These and other factors that may cause actual results to differ are more fully discussed in the "Risk Factors" section of Anadys' Form 10-Q for the quarter ended June 30, 2004. All forward-looking statements are qualified in their entirety by this cautionary statement. Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
CONTACT: Michael Kamdar, Sr. VP, Corporate Development and Finance,+1-858-530-3667, [email protected], or Pete De Spain, Manager, CorporateCommunications, +1-858-530-3653, [email protected], both of AnadysPharmaceuticals, Inc.; or In-Chull Kim, Ph.D., VP, Business Development,+82-2-3773-7009, [email protected], or Jay J.H. Kwon, Head of IR,+82-2-3773-3358, [email protected], both of LG Life Sciences, Ltd.
Web site: http://www.lgls.co.kr/
Web site: http://www.anadyspharma.com/
News Home
More Clinical Trials News
| 
发表于 2004-11-3 01:12
