ARTICLE | Clinical News

Hyperion's HPN-100 meets Phase III endpoint

November 2, 2010 10:55 PM UTC

Hyperion Therapeutics Inc. (South San Francisco, Calif.) said glycerol phenylbutyrate ( HPN-100) met the primary endpoint of non-inferiority to Buphenyl sodium phenylbutyrate in blood ammonia levels in a Phase III trial to treat urea cycle disorders (UCD). Specifically, ammonia levels for HPN-100 and Buphenyl were 34.7 and 38.4 umol/L, respectively. The four-week, double-blind, placebo-controlled, crossover, North American trial enrolled 45 patients. Hyperion said a pre-NDA meeting is scheduled with FDA for Dec. 7. Glycerol phenylbutyrate is a pre-prodrug of phenylacetic acid. ...