Fast Track for Shire Liver Fibrosis Drug

FDA has granted Shire a fast track designation for SHP626 (volixibat), an investigational drug for treating adults who have nonalcoholic steatohepatitis (NASH) with liver fibrosis. The company is developing SHP626 as a once daily, orally-administered inhibitor of the apical sodium dependent bile acid transporter, a protein that it says is primarily responsible for recycling bile acids from the intestine to the liver. NASH is a chronic liver disease for which there are currently no approved drugs for treatment.

The designation was based on data from preclinical and Phase 1 studies. Shire says it will initiate a randomized, placebo-controlled, double-blind Phase 2 study to evaluate the safety, tolerability and efficacy of three doses of volixibat over 48-weeks in adult patients with NASH. It will be conducted in the U.S., Canada and the United Kingdom.