Soligenix, Inc. has announced the initiation of patient enrollment for its Phase 2 clinical trial (DUS-AUBD-01) evaluating SGX945 (dusquetide) for the treatment of Behçet's Disease. The trial has received clearance from both the FDA and the Turkish Medicines and Medical Devices Agency.
Trial Design and Objectives
The pilot clinical trial is an open-label study designed to enroll approximately 25 patients aged 18 years or older who have been diagnosed with mild to moderate Behçet's Disease and are experiencing active oral and/or genital ulcers. Participants will receive SGX945 via a twice-weekly, four-minute intravenous (IV) infusion over a four-week period, followed by a four-week follow-up phase. The primary efficacy endpoints include assessing the extent and timeline of lesion clearance, as well as evaluating patient-reported quality of life improvements.
Rationale for Dusquetide in Behçet's Disease
"Our previous studies with dusquetide in oral mucositis have validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. He further added, "Given the role of the innate immune system in ulcers associated with Behçet's Disease, and the unmet medical need particularly for more severe ulcers such as genital and leg ulcers, we believe that dusquetide may offer significant relief to patients."
About SGX945 (Dusquetide)
Dusquetide, the active ingredient in SGX945, is an innate defense regulator (IDR), representing a novel class of short, synthetic peptides. Its mechanism of action involves modulating the body's response to injury and infection, promoting an anti-inflammatory, anti-infective, and tissue-healing environment. Dusquetide has demonstrated safety and tolerability in a Phase 1 clinical study involving 84 healthy volunteers. Prior Phase 2 and 3 clinical studies, which included over 350 subjects with oral mucositis resulting from chemoradiation therapy for head and neck cancer, have shown positive efficacy results and potential long-term ancillary benefits.
Behçet's Disease: An Unmet Medical Need
Behçet's Disease is a chronic, auto-immune, inflammatory disorder affecting blood vessels. Key symptoms include mouth sores (in approximately 95% of patients), skin rashes and lesions (approximately 50%), genital sores (approximately 50%), leg ulcers (approximately 40%), and eye inflammation (approximately 15%). There is currently no cure for Behçet's Disease; treatments focus on managing symptoms and reducing the frequency and severity of flares. Current treatments include corticosteroids, immunosuppressants, and anti-inflammatory drugs, each with limitations and potential side effects. Apremilast is the only approved drug for preventing oral ulcers in Behçet's Disease, but it requires continuous use and is associated with side effects such as diarrhea and nausea.
Anticipated Timeline
Soligenix anticipates completing enrollment in the Phase 2 trial and announcing study results in the first half of 2025.
