FDA grants Fast Track designation to SHP626 for adults with NASH, fibrosis

Shire announced the FDA has granted fast track designation to SHP626 as a treatment for adults with nonalcoholic steatohepatitis and liver fibrosis, according to a press release.

“Shire’s development plan for SHP626 is designed to address the unmet need in the treatment of adult patients who have NASH with liver fibrosis,” Philip J. Vickers, PhD, head of research and development at Shire, said in the release. “This fast track designation is further recognition of the critical need to develop new, effective therapeutic options for patients with this serious condition.”

Philip J. Vickers

Shire developed SHP626 because there are currently no approved drugs to treat NASH.

SHP626, also called volixibat, is taken orally once daily and works by inhibiting the apical sodium dependent bile acid transporter protein that recycles bile acids from the intestine to the liver.

During the phase 1 study, researchers assessed SHP626 in both healthy and obese individuals. The most common adverse effect was non-serious diarrhea. The only serious adverse effect was alanine aminotransferase elevation, which led to drug discontinuation.

The phase 2 randomized, placebo-controlled, double blind trial will evaluate the safety, efficacy and tolerability of three doses of SHP626 over 48 weeks. Researchers will conduct this study in the United States, Canada and the United Kingdom. – by Will Offit

Disclosure: Vickers is employed by Shire.