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Lumena Pharmaceuticals Launches Global Clinical Program to Evaluate Safety and Efficacy of LUM001 in Children with Alagille Syndrome
Date:9/26/2013

SAN DIEGO, Sept. 26, 2013 /PRNewswire/ -- Lumena Pharmaceuticals, a company developing oral therapeutics for rare liver diseases, today announced the initiation of a global clinical program to evaluate its drug candidate LUM001 in children with Alagille syndrome (ALGS). The first patient has been dosed in the IMAGO Phase II study being conducted in the U.K., and enrollment of pediatric patients is expected to begin later this year in the ITCH Phase II study in the U.S.

ALGS is a rare form of cholestatic liver disease that results in impaired bile acid flow and retention of bile acids in the liver, leading to progressive liver damage that can cause liver failure. LUM001 is being evaluated for its ability to lower serum bile acids and alleviate severe itching, which is generally the most debilitating symptom afflicting patients with the disease. By reducing serum bile acids with a once-daily oral solution, LUM001 may offer a novel therapeutic approach to prevent bile acid mediated liver damage and alleviate severe itching.

The IMAGO study is a 13 week placebo-controlled study to evaluate the safety and efficacy of LUM001 in children with ALGS. The U.K. based study will enroll children, two years of age and older, with ALGS.  

"Symptoms of Alagille syndrome include intense itching and sleep disruption on an ongoing basis, which is extremely problematic for the whole family when a child is suffering," said Alastair Baker, M.D., Consultant Paediatric Hepatologist, Kings College Hospital, London, and IMAGO study principal investigator. "Pedia
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