Anadys Pharmaceuticals Commences Dosing ANA598 in Hepatitis C Patients in Phase Ib Study
SAN DIEGO, Oct. 28 /PRNewswire-FirstCall/ — Anadys Pharmaceuticals, Inc. announced today that it has initiated dosing ANA598 in patients chronically infected with hepatitis C virus (HCV) in a Phase Ib study. ANA598 is an investigational, oral, non-nucleoside polymerase inhibitor. The Phase Ib clinical trial is a double-blind, placebo-controlled study that will evaluate the tolerability, pharmacokinetics and viral kinetics of multiple, ascending doses of ANA598 over a period of three days. Anadys expects to enroll approximately 30 patients in the study of ANA598 at doses of 200 mg bid (twice-a-day), 400 mg bid and 800 mg bid.
“ANA598 demonstrated favorable tolerability and pharmacokinetics as a single dose in healthy volunteers in our recently concluded Phase I study,” said James Freddo, M.D., Anadys’ Senior Vice President, Drug Development and Chief Medical Officer. “We look forward to building upon these results and testing the compound in HCV patients, first in this monotherapy study and subsequently in combination studies. We expect the maximal benefit of direct antivirals to be realized when used in combination regimens incorporating multiple anti-HCV agents.”
ANA598 Phase Ib Study
In the Phase Ib monotherapy study, ANA598 will be administered to naive genotype 1a and 1b patients over three days, at doses of 200 mg bid, 400 mg bid or 800 mg bid. Ten patients are planned to be enrolled in each of the three cohorts – eight on active treatment and two on placebo. Anadys expects to have viral load data from all three cohorts in the first quarter of 2009. Anadys may elect to explore other dose levels of ANA598 and/or once-daily dosing based on data from the first three cohorts.
In September, Anadys announced preliminary results of the Phase I clinical trial of ANA598 in healthy volunteers. This trial was designed to evaluate safety and pharmacokinetics in healthy volunteers receiving single doses ranging from 400 mg to 3000 mg. ANA598 was well tolerated in this study. It was well absorbed and the human pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with a half-life of 24 to 30 hours, consistent with the potential for once-daily or twice-daily oral dosing. All doses achieved plasma drug concentrations predicted to display substantial antiviral activity based on preclinical results. Safety and PK data from all dose levels in the Phase I clinical trial of ANA598 will be presented in a late-breaker poster session on November 3 at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), to be held in San Francisco, California. Further preclinical data on ANA598 will be presented at AASLD in two additional poster presentations on November 4.
Preclinical evaluation of ANA598 was completed in the first quarter of 2008, leading to submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA), subsequent allowance of the IND by the FDA and initiation of clinical investigation in the second quarter of 2008. In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day GLP toxicology studies.
Clinical Need and Market Opportunity in HCV Infection
Chronic HCV infection is a serious public health concern affecting approximately 3.2 million people in the United States and approximately 170 million people worldwide. HCV causes inflammation of the liver, which can lead to fibrosis and cirrhosis, and may ultimately lead to liver failure and/or liver cancer if not successfully treated. Cirrhosis of the liver resulting from chronic HCV infection is the leading indication for liver transplantation in the United States. Due to the asymptomatic nature of HCV infection, it often goes undetected for up to 20 years following initial infection. Each year, 8,000 to 10,000 people in the United States die from complications of HCV.
The current standard of care is a combination of pegylated interferon and ribavirin. Inadequate response rates, in particular for patients infected with genotype 1 HCV, along with significant side effects of approved therapy support the medical need for improved treatment options. It is estimated that fewer than 5% of people with chronic HCV infection living in the United States are under treatment today. Most infected individuals are unaware of their infection status and the large majority of individuals who know their condition do not currently receive drug therapy. There is also a growing number of individuals who have failed interferon-based regimens who may be successfully treated with combinations of two or more direct antivirals. It is expected that the next generation of therapies for treatment of HCV will include small molecules, such as ANA598, that directly act upon specific viral enzymes to inhibit viral replication. These new therapies are expected to improve overall therapy by increasing cure rates and potentially improving tolerability and convenience of treatment if doses of currently used agents can be reduced or eliminated.
Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. For the treatment of chronic hepatitis C, the Company is developing two potentially complementary agents: ANA598, a non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug. The Company is also developing ANA773 for the treatment of cancer.
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 (i) the expected occurrence, timing and trial design of the planned development activities for ANA598, including Anadys’ expectation that it will have viral load data from all three cohorts of the Phase Ib study in the first quarter of 2009; (ii) the expectation that the maximal benefit of direct antivirals will be realized when used in combination regimens incorporating multiple anti-HCV agents; (iii) the potential for once-daily or twice-daily oral dosing with ANA598; (iv) predictions of future antiviral activity of ANA598 based on plasma drug concentrations seen in the healthy volunteer study and preclinical results to date; and (v) expectations regarding the evolution of the market for HCV therapies. 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. For example, the results of preclinical and early clinical studies may not be predictive of future results, and Anadys cannot provide any assurances that ANA598 will not have unforeseen safety issues, will have favorable results in future clinical trials or 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 enter into collaborations around its product candidates, its ability to successfully develop and market products, difficulties or delays in its preclinical studies or clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments involving its product candidates and its ability to obtain additional funding to support its operations. Risk factors that may cause actual results to differ are more fully discussed in Anadys’ SEC filings, including Anadys’ Form 10-K for the year ended December 31, 2007 and Anadys’ Form 10-Q for the quarter ended September 30, 2008. 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.
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