Soligenix, Inc, a late-stage biotechnology company, has received European Patent Office patent EP 1392321 “Method of Treating Inflammatory Disorders of the Gastrointestinal Tract using Topically Active Corticosteroids.” 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.

These 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), an inflammatory condition arising from hematopoietic stem cell transplantation.

“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,” said Christopher J Schaber, president and CEO of Soligenix. “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.”

In addition to issued patents and pending worldwide patent applications held by or exclusively licensed to Soligenix, orBec also benefits from orphan drug designations in the US and in Europe for the treatment of GI GVHD, which provide for seven and 10 years of post-approval market exclusivity, respectively.

Beclomethasone dipropionate (BDP) is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue.

orBec represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of GVHD, the organ system where GVHD is most frequently encountered and highly problematic.

Soligenix is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents.