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news.Ore Pharmaceuticals has filed an investigational new drug application with the FDA for GL1001, the first clinical-stage inhibitor of the ACE2 enzyme.
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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.
Pending clearance of the investigational new drug (IND), the company plans to initiate a multiple ascending dose clinical trial in September 2008 to assess tolerability, pharmacokinetics and pharmacodynamics of GL1001.
Additionally, Ore Pharmaceuticals is undergoing preparations to test this first-in-class compound in later-stage clinical trials. The company is pursuing the clinical development of GL1001 in parallel with its efforts to establish an out-licensing or partnering arrangement to advance the compound into later-stage clinical trials.
Charles Dimmler III, Ore Pharmaceuticals’ CEO, said: “The filing of the first IND in the company’s history is a significant milestone for Ore Pharmaceuticals. We expect this first-in-class compound to be an attractive in-licensing candidate for pharmaceutical companies.”