Biotech Values

[DewDiligence]

Gilead’s Caspase Inhibitor Is Effective in NASH

[NASH is an acronym for Non-Alcoholic SteatoHepatitis, and it is unrelated to HBV and HCV. PFE has a similar compound, but I don’t know that program’s status.]

http://www.reuters.com/article/idCNN1524808920100416

›Fri Apr 16, 2010 12:00pm EDT

* 35 pct of high-dose patients achieved normal ALT levels

* 48 pct of high-dose patients achieved normal AST levels

LOS ANGELES, April 16 (Reuters) - Gilead Sciences Inc's <GILD.O> experimental drug, GS-9450, was shown in a mid-stage trial to improve markers of liver damage in patients with non-alcoholic steatohepatitis, the most serious form of liver disease in people who drink little or no alcohol.

Researchers said the Phase II trial, involving 124 patients, showed treatment with the drug reduced levels of alanine (ALT) and aspartate aminotransferases (AST), hepatic enzymes that indicate cell damage.

The results were presented on Friday in Vienna at the International Liver Congress.

GS-9450 is a caspase inhibitor designed to block proteins that initiate programmed cell death in damaged cells.

Gilead said the drug is a potential new treatment option for patients with non-alcoholic steatohepatitis, or NASH -- a disease characterized by fat in the liver, along with inflammation and damage such as scar tissue, cirrhosis and eventual liver failure.

Further studies are needed to evaluate the drug's efficacy and safety in larger patient populations.

The trial showed that, after four weeks, 35 percent patients treated with the highest dose of GS-9450 achieved ALT levels within the normal range. Forty-eight percent achieved normal levels of AST. Placebo treatment showed no meaningful change for either enzyme.‹