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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

ill be eligible for participation in a long-term extension study.  For more information about the IMAGO study, visit the study page at clinicaltrials.gov, a registry of funded research studies in the United States and around the world. Information about the ITCH study will also be available at clinicaltrials.gov once the study starts in the U.S.

"I think that I can speak on behalf of the Alagille syndrome community when I say that we enthusiastically support Lumena's work to develop safe, oral therapies to treat Alagille syndrome, and I am especially glad that the company is planning an extension study that allows for patients to have long-term access to this treatment while it is in development," said Cindy Hahn, founder and CEO of the Alagille Syndrome Alliance.

About LUM001

LUM001 is an inhibitor of the apical sodium-dependent bile acid transporter (ASBT), which recycles intestinal bile acids back into the circulation. LUM001 has been studied in 12 clinical trials in more than 1,400 subjects. In previous trials, LUM001 was shown to be generally safe, and the most common side effect, gastrointestinal disturbance, was usually mild and transient in nature. Clinical studies have demonstrated that LUM001 can reduce serum bile acid levels. Reductions in bile acids may alleviate symptoms and improve liver function in many patients with cholestatic liver disease.

Lumena plans to initiate Phase II studies of LUM001 in adults with primary biliary cirrhosis (PBC), children with progressive familial intrahepatic cholestasis (PFIC), and in patients with primary sclerosing cholangitis (PSC) in late 2013. Lumena has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) Office of Orphan Product Development for LUM001<
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