The Food and Drug Administration (FDA) has granted Fast Track designation to SHP626 (volixibat; Shire) for the potential treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis.

The FDA designation was based on data from preclinical and Phase 1 studies evaluating the safety, tolerability and preliminary activity of SHP626 vs. placebo in healthy and overweight or obese volunteers. The studies found that SHP626 exhibited a tolerable safety profile, with the most common adverse events presenting as gastrointestinal in nature. One serious adverse event, alanine aminotransferase elevation, was associated with SHP626 and led to treatment discontinuation. 

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Shire intends to initiate a multicenter, randomized, placebo-controlled, double-blind Phase 2 trial for three doses of volixibat to evaluate their safety, tolerability and efficacy over 48-weeks in adult patients with NASH.

SHP626 (volixibat) is an oral, once daily, apical sodium dependent bile acid transporter (ASBT) inhibitor.

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