9th Apr 2015 06:09
LONDON (Alliance News) - Shire PLC on Thursday said the phase two trial of its SHP625 investigational compound failed to meet primary or secondary endpoint goals in its study of pediatric patients with Alagille syndrome.
Alagille syndrome a rare genetic disorder which presents with chronic cholestasis, or accumulation of bile acids in the liver, and severe pruritus, or itching.
FTSE 100-listed Shire said mean serum bile acid levels and pruritus at the end of the study were lower in both SHP625 and placebo treated groups as compared to baseline.
But in a separate analysis, a positive correlation between the percent changes from baseline in serum bile acid levels and pruritis was observed in the SHP625 treated group. The number of patients in the placebo treated group was too small to make an accurate assessment of this relationship, Shire said.
"We have gained important insights from these first results from one of several phase 2 studies in the SHP625 development program," said Philip Vickers, head of research and development at Shire. "We remain committed to continuing the ongoing studies of SHP625 in ALGS and other indications."
By Sam Unsted; [email protected]; @SamUAtAlliance
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