Soligenix’s SGX945 shows efficacy in Phase 2 Behcet’s Disease trial

Soligenix (SNGX) has completed its Phase 2a proof of concept study evaluating SGX945 – dusquetide – in the treatment of Behcet’s Disease and achieved the study objective of demonstrating biological efficacy. Over 4 weeks of treatment, the area under the curve, average number of oral ulcers, and improvements in oral pain for SGX945 were similar to outcomes obtained in the apremilast study. Outcomes in weeks 5 through 8 continued to show similar outcomes to the apremilast study, even though apremilast treatment was continued through this period whereas SGX945 treatment was stopped at Week 4, per study design. The primary endpoint in the Phase 3 apremilast study was the AUC of the mean number of ulcers versus time. The SGX945 treated group had a 40% improvement relative to the placebo group from the Phase 3 apremilast study, whereas apremilast had a 37% improvement relative to placebo. This improvement was sustained throughout the 4-week follow-up after treatment with SGX945. Seven of 8 patients reported perceived benefit with SGX945 treatment. Some patients also explicitly reported experiencing less ulcers and pain during the 4-week follow-up period. Common adverse events for apremilast included diarrhea, nausea and headache, none of which were observed with SGX945.