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 regulatory decision was supported by Phase 2a data demonstrating biological efficacy and safety of the drug candidate. The orphan drug designation provides up to 10 years of market exclusivity in the European Union and adds to existing FDA orphan and fast track designations previously granted to the company.

This development represents a significant advancement for Soligenix’s innate defense regulator platform, which targets unmet medical needs in rare autoimmune conditions. Behçet Disease is a rare, chronic inflammatory disorder that can affect multiple body systems, including blood vessels, and currently has limited treatment options. The orphan designation in the EU facilitates development incentives including protocol assistance, reduced fees, and market exclusivity upon approval.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The company’s Specialized BioTherapeutics business segment includes development programs for dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and SGX945 in Behçet’s Disease. Additional information about the company’s developments is available through their newsroom at https://ibn.fm/SNGX.

The company’s broader development pipeline includes HyBryte (SGX301) as a novel photodynamic therapy for cutaneous T-cell lymphoma, with regulatory approvals being sought worldwide following successful completion of the second Phase 3 study. Expansion programs also include synthetic hypericin (SGX302) for psoriasis treatment. The Public Health Solutions business segment includes vaccine development programs incorporating proprietary heat stabilization platform technology known as ThermoVax®.

This regulatory milestone for dusquetide in Behçet Disease treatment represents progress toward addressing significant unmet needs in rare autoimmune conditions. The European orphan designation system is designed to encourage development of medicines for rare diseases that affect fewer than 5 in 10,000 people in the EU. Further details about the announcement can be found in the full press release at https://ibn.fm/847sO.

This news story relied on content distributed by InvestorBrandNetwork (IBN). Blockchain Registration, Verification & Enhancement provided by NewsRamp. The source URL for this press release is Soligenix Receives EU Orphan Drug Designation for Dusquetide in Behçet Disease Treatment.

The post Soligenix Receives EU Orphan Drug Designation for Dusquetide in Behçet Disease Treatment appeared first on citybuzz.