Soligenix Receives EU Orphan Drug Designation for Dusquetide in Behçet Disease Treatment

The European Commission has granted orphan drug designation to Soligenix Inc.'s dusquetide (SGX945) for the treatment of Behçet Disease, following a positive recommendation from the European Medicines Agency. This designation, which provides up to 10 years of market exclusivity in the European Union, builds upon existing FDA orphan and fast track designations for the compound. The decision was supported by Phase 2a data demonstrating biological efficacy and safety, as the company advances its innate defense regulator platform targeting unmet medical needs in rare autoimmune conditions.

Dusquetide represents a first-in-class innate defense regulator technology being developed for inflammatory diseases. The orphan drug designation in the European Union significantly enhances the compound's commercial potential by offering market protection and regulatory incentives designed to encourage development of treatments for rare diseases. This regulatory milestone comes as Soligenix continues to develop its Specialized BioTherapeutics business segment, which includes multiple development programs targeting conditions with limited treatment options.

The company's broader development pipeline includes HyBryte(TM) (SGX301) for cutaneous T-cell lymphoma, which has completed a second Phase 3 study, with regulatory approvals being sought worldwide. Additional programs include expansion of synthetic hypericin (SGX302) into psoriasis treatment and dusquetide (SGX942) for oral mucositis in head and neck cancer patients. The Public Health Solutions business segment continues development of vaccine candidates including RiVax(R) for ricin toxin, filovirus vaccines targeting Marburg and Ebola viruses, and CiVax(TM) for COVID-19 prevention.

Soligenix's vaccine development programs incorporate proprietary heat stabilization platform technology known as ThermoVax(R), with support from government agencies including the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA), and the Biomedical Advanced Research and Development Authority (BARDA). The company maintains its newsroom at https://ibn.fm/SNGX where investors can access the latest updates. This European orphan drug designation represents a significant step forward in addressing the treatment gap for Behçet Disease patients while strengthening Soligenix's position in the rare disease therapeutics market.