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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

tric patients have very little relief from the aggravating symptoms, and the need for treatment options is pressing."

"LUM001 represents a potential new approach to treating the progressive liver damage and symptoms associated with Alagille syndrome that severely affect a patient's quality of life," explained Benjamin Shneider, M.D., Pediatric Hepatologist, Children's Hospital of Pittsburgh of UPMC, the ITCH study chair. "Currently, there are no approved drugs to treat the cholestasis and pruritus associated with ALGS, and frequent options for children suffering with this disease are off-label treatments with limited efficacy and potential liver toxicity or surgical diversion of bile, which comes with risk of complications and quality of life issues."

The ITCH study is a multi-center U.S.-based study which is expected to begin later in 2013 and will be seeking pediatric patients, two years of age and older, with ALGS. The ITCH study is being conducted in collaboration with the Childhood Liver Disease Research and Education Network (ChiLDREN), a collaborative research network supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a part of the National Institutes of Health (NIH),which has a Cooperative Research and Development Agreement (CRADA) with Lumena. Lumena and ChiLDREN are also collaborating with European investigators to evaluate LUM001 in patients with progressive familial intrahepatic cholestasis (PFIC), another rare cholestatic liver disease.

"This public/private partnership is an example of a fruitful collaboration to find treatments for rare diseases," said Edward Doo, M.D., director of the Liver Diseases Research Program at NIDDK. "These cholestatic liver diseases have devastating symptoms and there is a significant need for additional treatment options, especially for children."

Patients that complete either the IMAGO or ITCH study w
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