Metabasis' hepatitis B drug pradefovir less damaging to kidneys than QD Hepsera, data suggests

By Angela McDaniels

Seattle, Nov. 15 - Metabasis Therapeutics Inc. said 24-week interim data from the phase 2 trial of the oral anti-viral compound pradefovir showed that the 30 milligram-doses of the drug released less adefovir into the blood stream than 10 milligram-doses of QD Hepsera.

Pradefovir is a prodrug designed for the treatment of hepatitis B and uses Metabasis' HepDirect technology, which delivers higher concentrations of adefovir to the liver while minimizing the levels of circulating adefovir and thus reducing exposure to the kidney where adefovir is believed to cause toxicity at high concentrations, the company said.

The data was presented Monday at the 56th annual meeting of the American Association for the Study of Liver Diseases.

Metabasis licensed pradefovir to Valeant under an agreement that included payment of a license fee and provides for additional payments upon the occurrence of certain milestones and payment of royalties to Metabasis on net sales should the product be approved for marketing and successfully commercialized, the company said.

The phase 2 study was conducted by Valeant is an multiple-dose study with 242 patients enrolled at 21 sites in the United States, Taiwan, Singapore and South Korea.

Hepatitis B is a potentially fatal disease that can lead to complications such as cirrhosis and liver cancer and is estimated to have infected two billion people worldwide. The hepatitis B market represents more than $1 billion in annual sales and is expected to grow to over $2.8 billion by 2012, the company said.

Metabasis Therapeutics is a San Diego, Calif.-based biopharmaceutical company that develops drugs to address chronic diseases involving pathways in the liver.

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