Shire's SHP625 fails to meet primary or secondary endpoints in Alagille syndrome trial
Ireland-headquartered drugmaker Shire (LSE: SHP) says that the 13-week Phase II IMAGO trial of investigational compound SHP625 did not meet the primary or secondary endpoints in the study of 20 pediatric patients with Alagille syndrome.
Alagille syndrome is a rare, life-threatening genetic disorder that presents with chronic accumulation of bile acids in the liver and severe itching.
The primary endpoint in this trial was the change from basis in serum bile acid levels as compared to placebo. The secondary endpoint of severe itching was assessed with the novel ItchRO instrument.
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