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Galmed Announces Initiation of a Clinical Development Program to Evaluate Aramchol meglumine for the Treatment of Primary Sclerosing Cholangitis (PSC)
The clinical research and development program will be conducted in collaboration with the Stravitz–Sanyal Institute for Liver Disease and Metabolic Health
About this update from Galmed Pharmaceuticals Ltd.
[{"type":"text","content":"The clinical research and development program will be conducted in collaboration with the Stravitz–Sanyal Institute for Liver Disease and Metabolic Health Virginia Commonwealth University. \nTEL AVIV, Israel, May 9, 2023 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (\"Galmed\" or the \"Company\"), a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases, today announced the initiation of a new clinical program to evaluate its lead compound, Aramchol meglumine for the Treatment of Primary Sclerosing Cholangitis (PSC).\n \nPSC is a chronic cholestatic liver disease, characterized by progressive and multifocal fibrosis of the biliary system, which typically results in cirrhosis and fibrotic liver disease. It is a rare disease with no approved treatment that qualifies for the status of an orphan disease in the United States and EU; it is estimated that ~70% of the PSC patients have underlying IBD, most frequently ulcerative colitis (UC).\nGalmed plans to initiate a Phase 2 study in the last quarter of 2023. The single-arm, open label, proof-of-concept clinical trial will evaluate the effects of 24 weeks of treatment with Aramchol meglumine in approximately 15 patients with PSC. The study's endpoints will include the conventional relevant laboratory parameters (alkaline phosphatase and bilirubin), sophisticated imaging including liver stiffness using MR Elastography (MRE), imaging of the biliary tract using MR cholangiopancreatography (MRCP) and hepatocyte-specific contrast agents, histological fibrosis and molecular assessment as well as a range of biomarkers of disease activity and fibrosis. These endpoints are expected to provide a robust assessment of the underlying disease and the effects of Aramchol.\nNotably most patients in the study are expected to suffer also from UC. Building on the strong rationale and pre-clinical data supporting the use of Aramchol in IBD, the study will also assess the status of UC, inflammatory markers and patients related outcomes (PROs).\nThe study will be conducted at the Stravitz–Sanyal Institute for Liver Disease and Metabolic Health Virginia Commonwealth University with Dr. Sayed Obaidullah Aseem as Principal Investigator.\nProf. Arun Sanyal, Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at VCU commented \"there is a great u...