Soligenix, Inc. announced on July 31, 2025, the successful completion of its Phase 2a proof-of-concept study evaluating SGX945 (dusquetide) in Behçet's Disease, achieving the objective of demonstrating biological efficacy. The study design was highly comparable to the Phase 3 study of apremilast (Otezla®), an approved drug for oral ulcers in Behçet's disease.
SGX945 showed a 40% improvement relative to placebo in the area under the curve (AUC) of oral ulcers after four weeks of treatment, compared to 37% for apremilast in its Phase 3 study. Notably, SGX945's improvement was sustained throughout a four-week follow-up period even after treatment cessation, while apremilast required continuous administration.
The study also highlighted SGX945's favorable safety profile, with no treatment-related adverse events reported, contrasting with common side effects like diarrhea and nausea associated with apremilast. Soligenix intends to pursue a reformulation of SGX945 to enable home-based subcutaneous treatment, further enhancing its market potential in this underserved orphan disease.
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