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FDA Grants Soligenix "Fast Track" Designation for Dusquetide in the Treatment of Oral Lesions of Behçet's Disease
PRINCETON, N.J., Jan. 8, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on
About this update from Soligenix, Inc.
[{"type":"text","content":"PRINCETON, N.J., Jan. 8, 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 its SGX945 (dusquetide) development program for the treatment of oral lesions of Behçet's Disease has received \"Fast Track\" designation from the U.S. Food and Drug Administration (FDA).\n\n \n \n \n \n \n \n\n \nFast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is intended to facilitate the development and expedite the review of new drugs and biologics. For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for SGX945 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months.\n\"We are very pleased to have SGX945 in Behçet's Disease granted fast track designation from the FDA,\" stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. \"As demonstrated by the granting of the designation, our previous studies with dusquetide in oral mucositis have clearly validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation. Behçet's disease is an unmet medical need in which the underlying vasculitis leads to ulceration of the mucous membranes and skin, with up to 18,000 people in the U.S. and as many as one 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 and look forward to initiating the Phase 2 clinical study in 2024.\"\nAbout Dusquetide\nDusquetide (the active ingredient in SGX945 (Behçet's disease) and SGX942 (oral mucositis)) is an innate defense regulator (IDR), a new class of short, synthetic peptides. It has a novel mechanism of...