Soligenix (NASDAQ: SNGX) announced that results from its Phase 2a proof-of-concept study evaluating SGX945 (dusquetide) for the treatment of aphthous ulcers associated with Behçet’s Disease have been published in Rheumatology (Oxford), reporting beneficial effects in seven of eight patients with sustained improvement through a four-week follow-up period after treatment ended. The company said outcomes for SGX945, including reductions in oral ulcers and pain and favorable area under the curve measurements, were comparable to those reported in a Phase 3 study of apremilast (Otezla(R)), despite SGX945 dosing stopping at Week 4 while apremilast required continuous administration. Soligenix noted SGX945 was well tolerated with no treatment-related adverse events observed and said it plans to pursue reformulation to enable home-based subcutaneous administration, while expanding development of dusquetide across additional innate immune-related inflammatory conditions and engaging regulators on a follow-on clinical study for this area of unmet medical need.
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About Soligenix
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte(TM) (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (SGX945) in Behcet’s Disease.
Our Public Health Solutions business segment includes development programs for RiVax(R), our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax(TM), our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax(R). To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).
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