FDA Grants Orphan Drug Designation for SGX945 to Treat Behçet's Disease

Soligenix's dusquetide, the active ingredient in SGX945, has been granted orphan drug designation by the FDA for the treatment of Behçet's Disease. This designation provides Soligenix with seven years of U.S. market exclusivity upon FDA approval. The designation was granted following review of recent Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet's Disease.

Soligenix, Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for dusquetide, the active ingredient in SGX945, for the treatment of Behçet's Disease [1]. This designation provides the company with seven years of U.S. market exclusivity upon FDA approval, offering significant regulatory advantages and financial benefits.

The designation was granted following the review of recent Phase 2a clinical results, which demonstrated biological efficacy and safety in patients with Behçet's Disease. The treatment targets a rare disorder affecting up to 18,000 people in the U.S. and approximately 1 million worldwide. The Phase 2 proof-of-concept study showed clinically meaningful improvements in patients with oral aphthous ulcers due to Behçet's Disease, addressing a significant unmet medical need in this chronic autoimmune condition [2].

Soligenix's dusquetide is an innate defense regulator (IDR), a new class of short, synthetic peptides. It modulates the body's reaction to both injury and infection towards an anti-inflammatory, anti-infective, and tissue healing response. The drug has demonstrated safety and tolerability in a Phase 1 clinical study in 84 healthy human volunteers and positive efficacy results in Phase 2 and 3 clinical studies with over 350 subjects with oral mucositis due to chemoradiation therapy for head and neck cancer [3].

The orphan drug designation for dusquetide in the treatment of Behçet's Disease strengthens Soligenix's intellectual property position and regulatory pathway for SGX945. This designation provides enhanced FDA interaction opportunities and a potentially streamlined approval process specifically designed for orphan drugs treating serious conditions with unmet needs. Additionally, the designation offers potential government grants for clinical trials, waiver of expensive FDA user fees for future New Drug Application submissions, and certain tax credits, significantly reducing development costs and improving ROI potential [2].

Behçet's Disease is a well-defined rare disease market with approximately 18,000 affected individuals in the U.S., 50,000 in Europe, and potentially 1 million worldwide. The concentration in certain regions (350,000 in Turkey) suggests targeted market opportunities [2]. The FDA's decision to grant orphan drug designation to the SGX945 program signifies an important step for Soligenix as it continues to advance the program and adds significantly to the existing intellectual property estate surrounding this novel technology [3].

References:
[1] https://www.marketscreener.com/news/soligenix-says-dusquetide-gets-orphan-drug-designation-from-us-fda-to-treat-behcet-s-disease-ce7c51dfd08ff026
[2] https://www.stocktitan.net/news/SNGX/fda-grants-soligenix-orphan-drug-designation-for-the-treatment-of-1ha7eiwia524.html
[3] https://ir.soligenix.com/2025-08-18-FDA-Grants-Soligenix-Orphan-Drug-Designation-for-the-Treatment-of-Behcets-Disease-after-Reviewing-Recent-Phase-2-Clinical-Study-Results