Agreements

Date: 2016-09-22

Type of information: Clinical research agreement

Compound: aramchol

Company: Galmed Pharmaceuticals (Israel) University of California, San Diego (USA - CA)

Therapeutic area: Hepatic diseases - Liver diseases

Type agreement: clinical research

Action mechanism: bile-acid conjugate. Aramchol is a conjugate of cholic acid and arachidic acid. This is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs). FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters. Aramchol affects liver fat metabolism and has been shown in a phase IIa clinical study to significantly reduce liver fat content as well as improve metabolic parameters associated with fatty liver disease.

Disease: non alcoholic fatty liver disease (NAFLD)

Details:

• • On September 22, 2016, Galmed Pharmaceuticals 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 Aramchol™ in a juvenile population with non alcoholic 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.
• The ARTISAN Study is subject to receipt of regulatory approvals and is currently expected to be initiated in the first half of 2017.

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