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Anadys Pharmaceuticals Initiates Phase I Clinical Trial of ANA975, an Oral Prodrug of Isatoribine for Hepatitis C

Posted on: Wednesday, 2 February 2005, 06:00 CST

SAN DIEGO, Feb. 2 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. , a biopharmaceutical company committed to the discovery, development and commercialization of novel anti-infective medicines, announced today that it has initiated a Phase I clinical trial of ANA975 in healthy volunteers. ANA975 is an oral prodrug of Anadys' proprietary small molecule compound isatoribine, an agonist of Toll-Like Receptor 7 (TLR7). Results from clinical trials of isatoribine have demonstrated a statistically significant viral load reduction in hepatitis C patients by activating innate immunity.

"We expect that ANA975 will provide the same combination of anti-viral effect and tolerability as observed with isatoribine, but with the added advantage of oral administration," said Steve Worland, Ph.D., Anadys' Executive Vice President, Research and Development. "The pharmaceutical properties of ANA975 along with the preclinical data further support our belief that ANA975 provides the potential to become an orally administered frontline treatment for chronic hepatitis C virus (HCV) infection."

The Phase I clinical trial is designed to evaluate the safety, tolerability and pharmacokinetics of ANA975 in healthy volunteers. The study is an open-label, ascending single-dose evaluation of ANA975 to be administered orally to a total of 18 subjects in three cohorts at 400 mg, 800 mg and 1200 mg doses. The trial is being conducted in the U.K.

ANA975 is an oral prodrug of Anadys' proprietary compound isatoribine. To date, isatoribine has been administered to 64 subjects, including 44 patients chronically infected with hepatitis C. Data from the Phase IB clinical trial of isatoribine, presented at the American Association for the Study of Liver Diseases (AASLD) 2004 Annual Meeting in Boston, provided the first reported evidence that a selective agonist of TLR7 can reduce circulating levels of HCV by activating innate immunity.

"We are very pleased to introduce ANA975 into the clinic ahead of schedule," said Kleanthis G. Xanthopoulos, Ph.D., Anadys' President and Chief Executive Officer. "We are using our expertise in Toll-Like Receptor-based biology and chemistry to build a strong portfolio of product candidates. We believe that we are at the forefront of this effort and have expanded our position around small molecules targeting Toll-Like Receptors."

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 medicines for the treatment of hepatitis C virus (HCV), hepatitis B virus (HBV) and bacterial infections. Anadys' clinical development programs include the oral prodrug ANA975 for the treatment of HCV and HBV, and ANA380 for the treatment of HBV. In addition, Anadys' anti-infective therapeutic platform, including core capabilities in Toll-Like Receptor-based small molecules and structure-based drug design, is designed to advance a strong and continual pipeline of drug candidates into the clinic.

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 viral load reduction resulting from administration of isatoribine to HCV infected patients and the effect on a patient's immune system, Anadys' expectation that ANA975 will provide the same combination of anti-viral effect and tolerability as Anadys has observed with isatoribine in early stage clinical trials, the believed potential for ANA975 to become an orally administered frontline treatment for chronic HCV, Anadys' efforts to utilize its expertise in Toll-Like Receptor based biology and chemistry to build a strong portfolio of product candidates and its belief that it is at the forefront of Toll-Like Receptor based biology and chemistry. 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 are not necessarily predictive of future results, and Anadys cannot provide any assurances that ANA975 will have favorable results in clinical trials, or 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 September 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.

Anadys Pharmaceuticals, Inc.

CONTACT: Michael Kamdar, Sr. VP, Corporate Development and Finance,+1-858-530-3667, cc@anadyspharma.com, or Pete De Spain, Manager, CorporateCommunications, +1-858-530-3653, pdespain@anadyspharma.com, both of AnadysPharmaceuticals, Inc.

Web site: http://www.anadyspharma.com/

Source: PRNewswire-FirstCall

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