SAN DIEGO and SEOUL, South Korea, Feb. 14 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. , a biopharmaceutical company committed to the discovery, development and commercialization of novel medicines for hepatitis, other serious infections and cancer, and L.G. Life Sciences, Ltd., the leading pharmaceutical company in South Korea, today announced principal findings from an open label, multi-center, dose-escalation Phase II clinical trial, evaluating the safety and antiviral activity of ANA380 (LB80380) in patients with lamivudine-resistant hepatitis B virus (HBV) infection.
These findings are based on an analysis of data from 12 weeks of dosing in 59 patients with lamivudine-resistant HBV. Each of the patients in the study had been previously treated with lamivudine, the current standard of care for HBV patients, and was documented to have genetically-encoded lamivudine resistance. In this Phase II clinical study, each of the patients was enrolled in one of five cohorts and received either 30 mg, 60 mg, 90 mg, 150 mg, or 240 mg of ANA380 once daily by oral administration for the 12 weeks of the study.
Patients receiving either 90 mg, 150 mg or 240 mg of ANA380 achieved robust viral load reductions in serum HBV DNA of 3.8 to 4.0 log10 units (greater than 99.9% clearance of the virus in plasma) at week 12. In addition to the significant viral load reduction observed, the levels of alanine aminotransferase (ALT) were also substantially reduced. A decline in ALT levels, a commonly used marker of hepatocyte injury, typically indicates a reduction in inflammation associated with HBV infection.
ANA380 was safe and well-tolerated in this study, and there were no serious adverse events (SAEs) or dose-limiting toxicities reported. However, definitive conclusions regarding product safety cannot be made until the results of future clinical trials of longer duration in more patients are known.
"These very encouraging Phase II data suggest that ANA380 may very well be the best-in-class among marketed HBV therapies as well as product candidates in development, particularly in difficult-to-treat patients with lamivudine-resistant HBV," said Kleanthis G. Xanthopoulos, Ph.D., President and Chief Executive Officer of Anadys. "By combining the antiviral potency, tolerability and activity against lamivudine-resistant virus with previously announced data from prior clinical trials with treatment-naive patients, we believe ANA380 appears to deliver tangible, clinical benefits both to patients who are treatment-naive and who have lamivudine-resistant HBV."
"We are delighted by ANA380's promising clinical results and believe that these results highlight the potential for ANA380 to be the next generation therapy for HBV patients," said In-Chull Kim, Ph.D., President and Chief Executive Officer of LG Life Sciences. "We are eager to move forward with Anadys to plan the next stages of clinical development."
"We can conclude from the clinical data that doses of 90 mg, 150 mg and 240 mg give similarly profound viral load reductions, enabling future clinical investigations of attractive dose levels," said Steve Worland, Ph.D., Anadys' Executive Vice President, Pharmaceuticals.
More detailed results from this trial, including viral load reduction and safety data for all cohorts, are scheduled for an oral presentation at the 41st Annual Meeting of The European Association for the Study of the Liver (EASL) in Vienna, Austria, April 26-30, 2006.
The development of viruses resistant to direct antiviral therapies is a growing problem in HBV-infected patients due to the virus' ability to rapidly mutate. Genetically-altered HBV that is resistant to lamivudine can be detected in 14 to 32 percent of patients after one year of lamivudine treatment and in more than 60 percent of patients after four years of treatment with lamivudine.
ANA380 is an oral prodrug of ANA317, a nucleotide analog for the treatment of chronic HBV infection. Anadys and LG Life Sciences are jointly developing ANA380 on a global basis. In April 2004, 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.
Previously reported results from a completed Phase I/IIa clinical trial of ANA380 demonstrated that oral administration of ANA380 over four weeks was both well-tolerated and reduced HBV viral load by 99.9 percent in the chronic HBV infected patients treated in the study.
In conjunction with Anadys' collaboration agreement with Novartis around ANA975 in HCV and HBV that was announced in June 2005, Anadys granted Novartis an exclusive option to evaluate and potentially license Anadys' rights to ANA380.
Hepatitis B is a growing global health problem that can cause both acute and chronic viral infections. Approximately 350-400 million people are chronically infected and have become carriers of HBV. Of those, approximately 15 to 40 percent will develop serious consequences of infection during their lifetime, including loss of liver function, cirrhosis, and liver cancer. According to the World Health Organization, approximately 1 million people die each year from chronic HBV or related conditions. The current annual market for HBV therapy is approximately $500 million and is expected to grow to more than $1 billion by 2009.
Anadys Pharmaceuticals, Inc. is a biopharmaceutical company committed to advancing patient care by discovering, developing and commercializing novel small molecule medicines for the treatment of hepatitis, other serious infections, and cancer. The Company has core expertise in Toll-Like Receptor- based small molecule therapeutics and structure-based drug design coupled with medicinal chemistry. Anadys' clinical development programs include ANA975 for the treatment of HCV and HBV, and ANA380 for the treatment of HBV. In addition, Anadys' 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") is the leading pharmaceutical company in South Korea with a firm foundation in science and R&D. LGLS strives to improve the health and quality of life of patients around the world through discovery, development and marketing of innovative products, including medicines to fight various infectious diseases, diabetes and other chronic illnesses. LGLS maintains successful partnerships with major pharmaceutical companies, augmenting its internal R&D and marketing capabilities. In 2005, LGLS generated approximately $204 million in revenue. LGLS seeks to continue developing global brand products, such as Factive(R) (gemifloxacin), and expanding its market presence in the world with focus in Asia.
Safe Harbor Statement
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to the potential for ANA380 to be the best-in-class therapy among HBV therapies and product candidates in development, the belief in its ability to deliver tangible, clinical benefits to both patients who are treatment-naÃ¯ve and patients who have lamivudine-resistant HBV, the potential for ANA380 to be the next generation therapy for HBV patients and references to Anadys and LGLS planning for the next stages of clinical development of ANA380, as well as references to the ability to conduct future clinical investigation of ANA380 at attractive dose levels and the belief that the dose response information gathered thus far will guide future clinical development options for ANA380. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys' actual results 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 cannot provide any assurances that any of its product candidates will have favorable results in future clinical trials or receive regulatory approval. In addition, Anadys' results may be affected by risks related to its collaborative relationships with Novartis and LGLS, competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to successfully develop and market products, the level of effort that its collaborative partners devote to development and commercialization of its product candidates, 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 September 30, 2005. 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.
Anadys Pharmaceuticals, Inc.