Ore Pharmaceuticals Inc. Files Investigational New Drug Application with FDA
Published: Jul 01, 2008
GAITHERSBURG, Md.--(BUSINESS WIRE)--Ore Pharmaceuticals Inc. (NASDAQ:ORXE) announced today that it has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for GL1001, the first clinical-stage inhibitor of the ACE2 enzyme. This orally administered small molecule is being developed primarily for inflammatory bowel disease (IBD). Treatment with GL1001 has decreased several disease activity measures in in vivo models of IBD as well as other gastrointestinal diseases with related injury due to inflammation. GL1001 was previously administered in a Phase I single ascending dose clinical study completed in the United Kingdom, where it was well tolerated and exhibited pharmacokinetics consistent with once daily dosing.