Galmed Pharma (GLMD), UCSD Enter Collaboration to Assess Aramchol in Juvenile Population

September 22, 2016 11:12 AM EDT

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Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced that it has signed an Investigator-Initiated Clinical Trial Agreement with the University of California, San Diego, School of Medicine (the "University"). The proposed study is a Phase I/IIa trial to assess safety, tolerability, efficacy, and pharmacokinetics of AramcholTM in a juvenile population with nonalcoholic fatty liver disease (NAFLD) (the "ARTISAN Study"). The ARTISAN Study (ARamcholTM Trial to Improve Steatosis in Adolescent NAFLD) is to be led by Dr. Jeffrey Schwimmer, Professor of Clinical Pediatrics at the University.

Fatty liver disease in children has been increasingly recognized as an important pediatric health problem. Pediatric NAFLD has some features that are similar to adults and several features that are unique to children. In the United States, there are an estimated 5 to 8 million children with NAFLD. The prevalence of NAFLD in children across the developed world is 5 to 10%. From a liver standpoint, the major concern is that NAFLD is a risk factor for cirrhosis and liver cancer. Beyond the risk for serious liver problems, children with NAFLD are also at increased risk for other important health problems including type 2 diabetes and atherosclerotic heart disease.

"NAFLD is the leading cause of chronic liver disease, yet there is no approved therapy in children or adults. Based upon promising data in adults, the University is developing a proof-of-concept trial for AramcholTM in adolescents with NAFLD," said Jeffrey Schwimmer, MD, professor of pediatrics, University of California, San Diego, School of Medicine and Director, Fatty Liver Clinic, Rady Children's Hospital, San Diego.

The ARTISAN Study is subject to receipt of regulatory approvals and is currently expected to be initiated in the first half of 2017.

Galmed's President and Chief Executive Officer, Mr. Allen Baharaff, stated "The ARTISAN Study marks the third investigator-initiated clinical trial and continues our strategy of collaborating with leading investigators to evaluate AramcholTM's efficacy across different populations and indications. We believe addressing the unmet need for treatment of juvenile population with NAFLD should not await the clinical development for adults. Based on AramcholTM's safety profile and mechanism-of-action, we decided to approach this important indication in parallel with our ongoing adult studies."

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