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 aims to assess the efficacy and safety of dusquetide in managing the aphthous ulcers, a common and debilitating symptom of Behçet's Disease.
The open-label, pilot study will enroll approximately 25 patients aged 18 years or older who have mild to moderate Behçet's Disease with 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 study's primary efficacy endpoints include the extent and timeline of lesion clearance, as well as patient-reported quality of life assessments. Results from the trial are anticipated in the first half of 2025.
Rationale Behind Dusquetide
Christopher J. Schaber, PhD, President and CEO 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."
Dusquetide, the active ingredient in SGX945, is an innate defense regulator (IDR). It modulates the body's response to injury and infection, promoting an anti-inflammatory, anti-infective, and tissue-healing environment. Unlike direct antibiotics, IDRs enhance the host's innate immune system, improving survival rates in infections caused by various bacterial pathogens. Dusquetide has also shown promise in accelerating tissue damage resolution following exposure to bacterial pathogens, trauma, and chemo- or radiation therapy.
Behçet's Disease: An Unmet 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 recurring mouth sores, skin rashes, 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 reducing the frequency and severity of flares. Existing treatments include corticosteroids, immunosuppressants (such as cyclosporine and cyclophosphamide), and anti-inflammatory drugs like anti-TNF medications. Apremilast is the only approved drug for Behçet's Disease, used as a maintenance therapy to prevent oral ulcers, but it has limitations, including continuous use requirements and side effects.
Soligenix hopes dusquetide will address the unmet medical need for more effective and tolerable treatments for Behçet's Disease, particularly for patients with severe ulcerations. The company has a strong intellectual property position in the IDR technology platform, including composition of matter for dusquetide and related analogs.
