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.
SGX945 has previously received orphan drug and fast track designations from the U.S. Food and Drug Administration for Behçet Disease. This regulatory progress is significant for patients suffering from this rare inflammatory disorder that causes blood vessel inflammation throughout the body, leading to symptoms including mouth sores, skin lesions, and eye inflammation. The positive EMA opinion represents a critical step toward making this potential treatment available to European patients who currently have limited therapeutic options.
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 is developing dusquetide as part of its first-in-class innate defense regulator technology platform. Beyond Behçet Disease, development programs in this segment include expansion of synthetic hypericin into psoriasis and dusquetide for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer.
The company's Public Health Solutions business segment includes development programs for RiVax, a 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. 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. More information about the company's developments is available at https://ibn.fm/SNGX.
The positive EMA opinion for dusquetide in Behçet Disease represents an important regulatory milestone that could accelerate development and eventual commercialization of this potential treatment. For the pharmaceutical industry, successful orphan drug designations demonstrate the viability of developing treatments for rare diseases, potentially encouraging more investment in this underserved area of medicine. The 10-year market exclusivity provision in the EU creates significant commercial incentives for companies willing to undertake the development of treatments for rare conditions with limited patient populations.
