Soligenix Inc witnessed a remarkable upswing in its stock on Thursday following the Food and Drug Administration’s (FDA) green light for its Investigational New Drug (IND) application concerning a Phase 2a clinical trial for SGX945 (dusquetide). The trial will focus on aphthous ulcers associated with Behçet’s disease, a rare vasculitic disorder known for affecting vessels of varying sizes and presenting a triple-symptom complex of recurrent oral aphthous ulcers, genital ulcers, and uveitis.
At the time of this publication, Soligenix Inc stock (SNGX) has witnessed a surge.
Soligenix Inc
Current Price: $1.38
Change : +0.96
Change (%): (232.21%)
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The study, designed to assess the safety and efficacy of SGX945, is poised to commence patient enrollment in the latter half of 2024. Behçet’s disease, characterized by its triple-symptom complex, represents an unmet medical need. It impacts a substantial number of individuals globally, with approximately 18,000 people in the United States, 80,000 in Europe, 350,000 in Turkey, and up to 1 million worldwide grappling with the challenges posed by this disorder.
Operating under this newly granted IND, the pilot clinical trial for SGX945 will adopt an open-label approach, with an estimated enrollment of 25 patients aged 18 years or older exhibiting mild to moderate Behçet’s disease with active oral and/or genital ulcers. The patients will receive SGX945 through a twice-weekly 4-minute intravenous (IV) infusion over the course of four weeks. The efficacy endpoints will encompass the extent of lesion clearance, the timeline to lesion clearance, and patient-reported quality of life indices.
Christopher J. Schaber, PhD, President, and Chief Executive Officer of Soligenix expressed satisfaction at securing FDA clearance for the Phase 2 pilot trial. “We are pleased to have received FDA clearance on our SGX945 Phase 2 pilot trial in aphthous ulcers of Behçet’s disease,” he stated.
The achievement of Soligenix Inc in gaining FDA approval for the Investigational New Drug application marks a significant milestone in the company’s pursuit of addressing the unmet medical needs associated with Behçet’s disease. With the commencement of the Phase 2a clinical trial, the company aims to contribute valuable insights into the safety and efficacy of SGX945 in managing aphthous ulcers in Behçet’s disease.
Behçet’s disease, due to its rarity and the associated challenges, has garnered attention as an area where medical advancements are crucial. The potential impact of SGX945 on lesion clearance and the overall improvement in patients’ quality of life is eagerly anticipated. Soligenix’s strategic approach, as evidenced by the open-label pilot trial, reflects a commitment to transparency and robust evaluation of SGX945’s performance.
As the company prepares to embark on patient enrollment in the latter part of 2024, the stock surge underscores the investor confidence in Soligenix’s innovative endeavors. The pharmaceutical landscape eagerly awaits the outcomes of the Phase 2a clinical trial, recognizing the potential significance of SGX945 in addressing the multifaceted challenges posed by Behçet’s disease.
