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.
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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