PRINCETON, N.J. - Soligenix, Inc. (NASDAQ:SNGX), a biopharmaceutical company, has announced the establishment of a Medical Advisory Board (MAB) to guide clinical development of its drug candidate SGX945 (dusquetide) for Behçet's Disease. The company plans to initiate a Phase 2a clinical study later in 2024, following the Fast Track designation granted by the U.S. Food and Drug Administration for the treatment of oral lesions associated with the disease.
The MAB comprises leading rheumatologists with significant experience in Behçet's Disease, tasked with advising on the clinical study's conduct and subsequent trials. Among the appointed experts is Dr. Gülen Hatemi, who leads the world’s largest Behçet's research center at Istanbul University – Cerrahpaşa, and Dr. Johannes Nowatzky of NYU Grossman School of Medicine, who directs the NYU Behçet's Disease Center.
Dusquetide, the active ingredient in SGX945, is classified as an innate defense regulator (IDR), a new class of synthetic peptides designed to modulate the body’s response to injury and infection by promoting anti-inflammatory and tissue healing responses. The drug has shown safety and tolerability in a Phase 1 study involving 84 healthy volunteers and has demonstrated positive efficacy results in over 350 subjects with oral mucositis in Phase 2 and 3 studies.
Behçet's Disease, a vasculitis typically diagnosed in young adults, causes symptoms such as mouth sores, skin lesions, and eye inflammation, impacting patients' quality of life. Current treatments focus on symptom management, with no cure available. Soligenix's IDR technology platform, which includes dusquetide, holds a robust intellectual property position, with the drug being developed based on discoveries from the University of British Columbia, Canada.
Soligenix's broader portfolio includes HyBryte™ for cutaneous T-cell lymphoma and Public Health Solutions like RiVax®, a ricin toxin vaccine candidate, and CiVax™ for COVID-19 prevention. The company's vaccine development benefits from its proprietary ThermoVax® heat stabilization platform technology.
This news piece is based on a press release statement from Soligenix, Inc. and does not include any additional commentary or speculative information.
InvestingPro Insights
As Soligenix, Inc. (NASDAQ:SNGX) advances its clinical development for SGX945, investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, Soligenix has a market capitalization of $6.73 million USD and holds more cash than debt on its balance sheet, which is a positive sign for stability and potential growth. However, the company is quickly burning through cash and analysts expect a sales decline in the current year.
InvestingPro Tips suggest that Soligenix's stock price movements are quite volatile, with the company's stock having fared poorly over the last month, showing a -25.52% return. Over the last three months, the stock has seen a strong return of 55.77%, indicating some recovery. It's important to note that Soligenix does not pay a dividend to shareholders, which may influence investment decisions for those seeking regular income.
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