Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), 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” with the latest issuing October 24, 2018, following the expiration of the objection period as of July 24, 2019. 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.
SGX201 and OrbeShield® are proprietary oral formulations of BDP that function as mucosally delivered steroidal treatments for the GI tract while minimizing systemic steroid side effects, including risk of severe infection. SGX201 utilizes an enteric coated tablet to deliver steroid to the distal GI tract, while OrbeShield® employs both immediate and delayed release, enteric-coated formulations to cover both the proximal and distal GI tract. Due to the low systemic bioavailability of BDP, these formulations maximize anti-inflammatory steroid action at the site of injury, while minimizing common side effects of steroids, including immune suppression, enabling their use in expanded populations.
SGX201 has been evaluated in the treatment of acute radiation enteritis in patients with rectal carcinoma. Future studies may include the evaluation of oral BDP in patients with gynecological cancers at risk of acute and chronic radiation enteritis due to radiation therapy. OrbeShield® is being developed in the biodefense context, as a potential treatment in the event of radiation exposure in a mass casualty incident. The combination of immediate and delayed release oral BDP is also being developed as a treatment for Pediatric Crohn’s Disease in Soligenix’s SGX203 program, for which a pivotal Phase 3 clinical trial protocol has been agreed with U.S. Food and Drug Administration (FDA). The conduct of the Phase 3 trial in Pediatric Crohn’s Disease is pending partnership and/or additional funding.
“Soligenix continues to evaluate opportunities for its proprietary formulations of oral BDP,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “These therapeutic use patents are generally valid until 2029 and allow us to expand our intellectual property portfolio across the two business segments of our rare disease pipeline.”