Soligenix Receives Positive EMA Orphan Drug Opinion for Dusquetide in Behçet Disease

The European Medicines Agency Committee for Orphan Medicinal Products has issued a positive recommendation for orphan drug designation of dusquetide, the active ingredient in SGX945, for the treatment of Behçet Disease. This recommendation follows review of recently published Phase 2a data demonstrating biological efficacy and safety, and now advances to the European Commission for ratification. The orphan designation in the European Union provides 10 years of market exclusivity upon approval, along with development incentives and centralized authorization access, which could significantly impact treatment availability for this rare disease.

SGX945 has previously received orphan drug and fast track designations from the U.S. Food and Drug Administration for Behçet Disease, indicating regulatory recognition of the treatment's potential importance. The company's development programs include expansion of synthetic hypericin (SGX302) into psoriasis, and its first-in-class innate defense regulator technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer. The latest news and updates relating to SNGX are available in the company's newsroom at https://ibn.fm/SNGX.

The Public Health Solutions business segment includes development programs for RiVax, the company's ricin toxin vaccine candidate, as well as vaccine programs targeting filoviruses such as Marburg and Ebola, and CiVax, a vaccine candidate for the prevention of COVID-19. The development of these vaccine programs incorporates the use of proprietary heat stabilization platform technology known as ThermoVax. This business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases, the Defense Threat Reduction Agency and the Biomedical Advanced Research and Development Authority.

The positive EMA opinion represents a significant regulatory milestone that could accelerate development and potential commercialization of dusquetide for Behçet Disease patients in Europe. Orphan drug designations are particularly important for rare diseases where treatment options are limited, as they provide financial incentives and regulatory support to encourage development of therapies that might otherwise be economically unviable. The 10-year market exclusivity period upon approval creates a protected commercial environment that can justify the substantial investment required for rare disease drug development.

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