Soligenix Receives European Patents for Oral BDP in the Treatment of Acute Radiation Injury of the Gastrointestinal Tract
Patents cover SGX201 in acute radiation enteritis and OrbeShield® for acute total body irradiation.
Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the European Patent Office has issued two patents, both titled "Topically Active Steroids for use in Radiation and Chemotherapeutics Injury". The new patents (#2,373,160 and #2,902,031) claim use of oral beclomethasone 17,21-dipropionate (BDP) for treatment of damage to the gastrointestinal (GI) tract as a result of acute radiation injury, including total body irradiation in an accidental or biodefense context.
About SGX201 and OrbeShield
SGX201 is formulated for oral administration in cancer patients as a single product consisting of a delayed release (enteric coated) tablet which releases BDP in the distal portions of the GI tract. SGX201 has been awarded fast-track designation from the FDA for the prevention of radiation enteritis. Previous studies with SGX201 have been supported by a National Cancer Institute Small Business Innovation Research (SBIR) grant #R43CA141968.
OrbeShield is formulated for oral administration in gastrointestinal acute radiation syndrome (GI ARS) patients as a single product consisting of two tablets. One tablet releases BDP in the proximal portions of the GI tract, and the other tablet releases BDP in the distal portions of the GI tract. OrbeShield has also been granted Orphan Drug and Fast Track designations by the FDA for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster. OrbeShield development as a medical countermeasure for GI ARS has been supported by the Biomedical Advanced Research and Development Authority (BARDA) (contract #HHSO100201300023C) and the National Institute of Allergy and Infectious Diseases (NIAID) (contract #HHSN27220130030C) contracts.