Soligenix Inc. (NASDAQ:SNGX) said the European Commission has granted orphan drug designation to dusquetide, the active compound in its investigational therapy SGX945, for the treatment of Behçet’s Disease.
The designation follows a favorable opinion from the European Medicines Agency’s Committee for Orphan Medicinal Products, which evaluated previously published Phase 2a clinical trial data for the treatment.
Orphan drug designation in the European Union provides developers with up to 10 years of market exclusivity following regulatory approval. The status also offers development incentives, including protocol assistance and access to centralized marketing authorization procedures across the EU. Such designation is reserved for therapies targeting life-threatening or chronically debilitating conditions affecting fewer than five in 10,000 people in the EU when satisfactory treatment options are limited or unavailable.
SGX945 has previously received both orphan drug designation and fast track status from the U.S. Food and Drug Administration for Behçet’s Disease. The therapy has also been granted Promising Innovative Medicine status by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency.
“We are extremely pleased to have received European orphan drug designation for the SGX945 program,” said Christopher J. Schaber, President and Chief Executive Officer of Soligenix. “Behçet’s Disease is an area of unmet medical need, with up to 18,000 people in the U.S., 50,000 people in Europe, 350,000 people in Turkey and as many as 1 million people worldwide affected by this incurable disease.”
Behçet’s Disease is a rare inflammatory disorder that affects blood vessels and is typically diagnosed in young adults. Common symptoms include oral ulcers, which occur in about 95% of patients, skin lesions and rashes affecting roughly half of patients, and genital ulcers in approximately 50% of cases. There is currently no cure, and available treatments primarily aim to control symptoms and manage inflammation.