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Soligenix Receives FDA IND Clearance for Phase 2 Clinical Trial of Dusquetide in the Treatment of Aphthous Ulcers in Behçet's Disease
Pipeline Expansion of Novel Innate Defense Regulator Technology PRINCETON, N.J., Nov. 30, 2023 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or
About this update from Soligenix, Inc.
[{"type":"text","content":"Pipeline Expansion of Novel Innate Defense Regulator Technology\nPRINCETON, N.J., Nov. 30, 2023 /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 the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 2a clinical trial entitled, \"Pilot Study of SGX945 (Dusquetide) in the Treatment of Aphthous Ulcers in Behçet's Disease.\" The study is designed to evaluate the safety and efficacy of SGX945 (dusquetide) and is expected to begin patient enrollment in the second half of 2024.\n\n \n \n \n \n \n \n\n \n\"We are pleased to have received FDA clearance on our SGX945 Phase 2 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 clearly 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 unmet medical need, with up to 18,000 people in the U.S., 80,000 in Europe, 350,000 people in Turkey and as many as 1 million people worldwide affected by this incurable disease. Given our promising results 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 disease.\"\nUnder this IND, the 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 active oral and/or genital ulcers. Patients will receive SGX945 as a twice weekly 4-minute intravenous (IV) infusion for 4 weeks. Efficacy endpoints will include t...