Soligenix, a late-stage biotechnology company, has received patent EP 1392321 'Method of Treating Inflammatory Disorders of the Gastrointestinal Tract using Topically Active Corticosteroids,' from the European Patent Office.
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Soligenix said that the new patent’s main claims cover the use of topically active corticosteroids in orally administered dosage forms that act concurrently in the upper and lower gastrointestinal tract.
Reportedly, the dosage forms include orBec, an oral formulation of beclomethasone dipropionate (BDP), a topically active corticosteroid, currently in a confirmatory Phase 3 clinical trial for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD).
Soligenix claimed that in addition to issued patents and pending patent applications held by or licensed to Soligenix, orBec also benefits from orphan drug designations in the US and in Europe for the treatment of GI GVHD.
Christopher Schaber, president and CEO of Soligenix, said: “The granting of the European patent strengthens our intellectual property portfolio in the field of topically active steroids. It demonstrates the novelty and utility of our approach to treating inflammatory GI diseases, such as GI GVHD with our two-pill system comprising an immediate-release and a delayed-release combination of oral BDP.
“This is the first European patent in our portfolio that addresses topically active formulations of corticosteroids, and we expect additional patents will be granted in the near future. We believe that our oral BDP formulations may also have utility in other inflammatory GI diseases, such as radiation enteritis, irritable bowel syndrome and Crohn’s disease.”
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