SHP625: Phase II data

Top-line data from the double-blind, U.K. Phase II IMAGO trial in 20 patients ages 1-18 with Alagille syndrome showed that once-daily oral SHP625 missed the primary endpoint of reducing fasting serum bile acid levels from baseline to week 13 vs. placebo (reduction of 66.1 vs. 42.1 umol/L, p=0.69). SHP625 also missed the secondary endpoints of reducing pruritus as measured by ItchRO(Obs) scores (reduction of 0.61 vs. 0.59 points, p=0.95) and of improving liver enzymes vs. placebo. There were no treatment-emergent serious adverse events reported and the most common adverse events reported were diarrhea and abdominal pain. Patients received placebo or once-daily 140 or 280 ug/kg SHP625. ...