Positive Clinical Results from Phase 2 Trial of SGX945 for the Treatment of Behçet's Disease Published in Rheumatology (Oxford)

Core Insights - Soligenix, Inc. has published results from its Phase 2a study of SGX945 (dusquetide) for treating Behçet's Disease, indicating promising outcomes for patients with oral ulcers associated with the condition [1][2][5] Study Results - The Phase 2a study showed beneficial effects for 7 out of 8 patients over 4 weeks of treatment, with sustained improvements noted during the follow-up period [2][4] - SGX945 demonstrated a 40% improvement in the area under the curve (AUC) for the mean number of ulcers compared to placebo, while the approved drug apremilast showed a 37% improvement [3][9] - Improvements in oral pain were consistent with the AUC measurements, with 7 of 8 patients reporting benefits such as reduced duration and number of oral ulcers [4][9] Safety and Tolerability - SGX945 was well-tolerated with no treatment-related adverse events reported, contrasting with common side effects associated with apremilast, such as diarrhea (41%), nausea (19%), and headache (14%) [4][9] Future Development Plans - The company plans to reformulate SGX945 for home-based treatment via subcutaneous injection and aims to expand its development into other inflammatory conditions related to the innate immune system [5][10] - Soligenix holds a strong intellectual property position for dusquetide and has received Fast-Track and Orphan Drug designations from the FDA for its treatment of Behçet's Disease [10][12] Market Context - Behçet's Disease is a chronic condition affecting approximately 1 million people worldwide, with significant unmet medical needs, particularly in managing symptoms like oral ulcers [11][12] - Current treatments, including apremilast, require continuous administration and are associated with high costs and side effects, highlighting the potential market opportunity for SGX945 [14][15]