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SGX945 Demonstrates Encouraging Efficacy and Safety in Phase IIa Behçet’s Disease Study

SGX945 Demonstrates Encouraging Efficacy and Safety in Phase IIa Behçet’s Disease Study

Soligenix has reported positive results from a Phase IIa proof-of-concept trial evaluating SGX945 (dusquetide) for the treatment of oral ulcers associated with Behçet’s disease. In the open-label study, seven of eight patients reported meaningful benefits over four weeks of treatment, including fewer ulcers, shorter ulcer duration, and reduced pain. Notably, these improvements appeared to persist during a four-week follow-up period after treatment cessation.

The study benchmarked outcomes against data from the Phase III apremilast (Otezla) trial. SGX945 demonstrated comparable efficacy across key measures, including area under the curve (AUC) for mean ulcer count, average ulcer burden, and pain reduction. Using apremilast’s primary endpoint, SGX945 achieved a 40% improvement versus placebo at week four, with benefits largely maintained through week eight despite discontinuation.

SGX945 was well tolerated, with no treatment-related adverse events reported, contrasting with the gastrointestinal and neurological side effects seen with apremilast.

23-12-2025