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Published on 10/18/2006 in the Prospect News Biotech Daily.

Anadys preparing to bring ANA975 back to clinic

By Jennifer Lanning Drey

Portland, Ore., Oct. 18 - Anadys Pharmaceuticals, Inc. will perform a new toxicology study of ANA975 and plans to bring the drug back into the clinic as soon as possible, Kleanthis G. Xanthopoulos, president and chief executive officer of Anadys said Wednesday at the 2006 BIO Investor Forum in San Francisco.

"We believe we can take specific steps to address the concerns that we have and more fully understand how we can use these very powerful molecules," Xanthopoulos said.

Anadys suspended dosing hepatitis C virus patients in a phase 1b clinical trial with ANA975 in June after a preliminary analysis of toxicology studies showed intense immune stimulation in monkeys.

Xanthopoulos said Wednesday that further analysis of the toxicology data showed the response to be mostly mechanistically based, and the new toxicology study will be designed to be appropriate for the biological responses seen.

"It's now up to us to figure out how to use these very powerful compounds to move forward," Xanthopoulos said.

Anadys wants to have ANA975 in the clinic as quickly as possible and plans to proceed with patient dosing of the drug at 800 mg and 1,000 mg, he said.

The company plans to meet with the Food and Drug Administration to discuss the new toxicology study, Xanthopoulos also said.

In its hepatitis B virus program, Anadys is preparing to begin phase 2b studies of ANA380, Xanthopoulos said Wednesday.

The company and the FDA have agreed that once complete, Anadys will begin a phase 3 clinical trial of the drug based on the six-month data from the phase 2b study.

"380 is a compound that demonstrates a lot of attributes, and we think it's going to be very competitive in an immature expanding market," Xanthopoulos said.

Anadys is a San Diego biopharmaceutical company.


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