Soligenix 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, cleared by both 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 disease.
Trial Design and Objectives
The Phase 2 pilot study is an open-label trial 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, 4-minute intravenous (IV) infusion over a four-week period, followed by a four-week follow-up phase. The primary efficacy endpoints include the extent and timeline of lesion clearance, as well as patient-reported quality of life assessments.
Dusquetide: A Novel Innate Defense Regulator
Dusquetide, the active ingredient in SGX945, is classified as 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, shifting it towards an anti-inflammatory, anti-infective, and tissue-healing pathway. Unlike traditional antibiotics, IDRs do not directly target pathogens but instead enhance the host's innate immune system to improve survival rates in infections caused by a wide range of bacteria.
Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix, stated, "Our previous studies with dusquetide in oral mucositis have validated the biologic activity in 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."
Behçet's Disease: An Unmet Medical Need
Behçet's Disease is a chronic inflammatory disorder affecting blood vessels, characterized by recurrent oral ulcers, skin lesions, genital sores, leg ulcers, and eye inflammation. The disease, believed to have both genetic and environmental factors, is most prevalent along the "Silk Road," including countries such as Turkey, Iran, Japan, and China. While the exact number of cases varies, estimates suggest that up to 18,000 people in the U.S., 50,000 in Europe, and as many as 1 million people worldwide are affected by this incurable condition.
Currently, there is no definitive cure for Behçet's Disease; treatment strategies focus on managing symptoms and reducing the frequency and severity of flares. Existing therapies include corticosteroids, immunosuppressants, and anti-inflammatory drugs, each with its own limitations and potential side effects. Apremilast is the only approved drug for Behçet's Disease, used as a maintenance therapy to prevent oral ulcers, but it requires continuous use and can cause adverse effects such as diarrhea and nausea.
Anticipated Timeline
Soligenix anticipates completing patient enrollment and announcing the study results in the first half of 2025. The outcome of this Phase 2 trial could provide valuable insights into the potential of dusquetide as a novel therapeutic option for individuals with Behçet's Disease, particularly those with severe ulcerations.
