Soligenix, Inc. has commenced patient enrollment in a Phase 2 clinical trial (DUS-AUBD-01) to investigate SGX945 (dusquetide) for the treatment of Behçet's Disease. The trial, cleared by the FDA and the Turkish Medicines and Medical Devices Agency, marks a significant step in addressing the unmet medical needs of individuals suffering from this chronic auto-immune condition.
The open-label pilot study will enroll approximately 25 patients aged 18 years or older who have mild to moderate Behçet's Disease and active oral and/or genital ulcers. Participants will receive SGX945 via a twice-weekly, 4-minute intravenous infusion over a 4-week period, followed by a 4-week follow-up. The primary efficacy endpoints include the extent and timeline of lesion clearance, as well as patient-reported quality of life assessments.
Dusquetide's Mechanism of Action
Dusquetide, the active ingredient in SGX945, is an innate defense regulator (IDR). This novel class of short, synthetic peptides modulates the body's response to injury and infection, promoting an anti-inflammatory, anti-infective, and tissue-healing environment. Unlike antibiotics, IDRs enhance the host's innate immune system, increasing survival rates in infections caused by various bacterial pathogens. Dusquetide has also demonstrated the ability to accelerate tissue repair following exposure to bacterial pathogens, trauma, and chemo- or radiation therapy.
Clinical History and Potential Benefits
Previous studies with dusquetide in oral mucositis have shown promising biologic activity in treating aphthous ulcers induced by chemotherapy and radiation. "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," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.
Dusquetide has demonstrated safety and tolerability in a Phase 1 clinical study involving 84 healthy volunteers. Phase 2 and 3 clinical studies involving over 350 subjects with oral mucositis have also shown positive efficacy results, including potential long-term ancillary benefits.
Behçet's Disease: An Unmet Medical Need
Behçet's Disease, a chronic inflammatory disorder affecting blood vessels, impacts an estimated 18,000 individuals in the U.S., 50,000 in Europe, 350,000 in Turkey, and up to 1 million people worldwide. Characterized by recurrent oral sores, skin lesions, genital sores, leg ulcers, and eye inflammation, the disease significantly diminishes patients' quality of life and their ability to engage in daily activities.
Currently, there is no cure for Behçet's Disease. Treatments focus on managing symptoms and addressing flares with corticosteroids, immunosuppressants, and anti-inflammatory drugs. Apremilast is the only approved drug for preventing oral ulcers, but it requires continuous use and is associated with side effects and high costs.
Soligenix anticipates completing enrollment and announcing study results in the first half of 2025. The trial's findings could provide a valuable new therapeutic option for patients with Behçet's Disease, addressing a significant unmet medical need.
