Business
Soligenix Initiates a Phase 2 Clinical Trial of SGX945 (dusquetide) for the treatment of Behçet's Disease
Study DUS-AUBD-01 opens patient enrollment PRINCETON, N.J., Nov. 14, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a
About this update from Soligenix, Inc.
[{"type":"text","content":"Study DUS-AUBD-01 opens patient enrollment\nPRINCETON, N.J., Nov. 14, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has opened patient enrollment for its Phase 2 study (protocol number DUS-AUBD-01) evaluating SGX945 (dusquetide) in the treatment of Behçet's Disease.\n\n \n \n \n \n \n \n\n \n\"We are pleased to have received FDA clearance and Turkish Medicines and Medical Devices Agency (Turkey's Ministry of Health) authorization to start patient enrollment into our SGX945 Phase 2a pilot trial in aphthous ulcers of Behçet's Disease,\" stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. \"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. We are excited to expand dusquetide's development into different innate immune-related inflammatory conditions, such as Behçet's Disease, as a component of our long-term strategy to enhance the value of this unique compound. Behçet's Disease is an area of unmet medical need, with up to 18,000 people in the U.S., 50,000 in Europe, 350,000 people in Turkey and as many as 1 million people worldwide affected by this incurable disease. Given the promising biologic activity observed with aphthous ulcers in oral mucositis, we are hopeful dusquetide will have a role to play in helping underserved patients suffering from this difficult to treat and chronic auto-immune disease. We look forward to completing enrollment and announcing study results in the first half of 2025.\"\nThe pilot clinical trial of SGX945 will be an open-label study that will enroll approximately 25 patients age 18 years or older with mild to moderate Behçet's Disease and active oral and/or genital ulcers. Patients will receive SGX945 as a twice weekly 4-minute intravenous (IV) infusion for 4 weeks followed by 4 weeks of follow-up. Efficacy endpoints...