Soligenix Inc. has announced publication of positive results from its Phase 2a proof-of-concept study evaluating SGX945 for treating aphthous ulcers associated with Behçet's Disease. The data, published in Rheumatology (Oxford), demonstrated beneficial effects in seven of eight patients with sustained improvement through a four-week follow-up period after treatment concluded.
The study outcomes for SGX945 included reductions in oral ulcers and pain, along with favorable area under the curve measurements. These results were comparable to those reported in a Phase 3 study of apremilast (Otezla), despite SGX945 dosing stopping at Week 4 while apremilast requires continuous administration. This distinction suggests SGX945 may offer treatment advantages for patients seeking therapies with limited dosing schedules.
Soligenix reported SGX945 was well tolerated with no treatment-related adverse events observed during the study. The company plans to pursue reformulation to enable home-based subcutaneous administration, potentially increasing accessibility for patients managing this chronic condition. Additional development plans include expanding dusquetide across other innate immune-related inflammatory conditions and engaging regulators on a follow-on clinical study for this area of unmet medical need.
Behçet's Disease represents a significant therapeutic challenge as a rare, chronic inflammatory disorder characterized by recurrent oral and genital ulcers, skin lesions, and potential systemic complications affecting multiple organs. Current treatment options remain limited, creating substantial unmet medical needs for affected patients worldwide. The positive Phase 2a results for SGX945 suggest potential for addressing these needs through a novel therapeutic approach.
Soligenix's broader development pipeline includes multiple programs across its Specialized BioTherapeutics and Public Health Solutions business segments. The company's Specialized BioTherapeutics segment focuses on developing HyBryte for cutaneous T-cell lymphoma treatment, with regulatory approvals sought following successful Phase 3 study completion. Additional programs include expansion of synthetic hypericin into psoriasis treatment and dusquetide development for inflammatory diseases including oral mucositis in head and neck cancer patients.
The Public Health Solutions segment incorporates vaccine development programs targeting ricin toxin, filoviruses including Marburg and Ebola, and CiVax for COVID-19 prevention. These programs utilize the company's proprietary ThermoVax heat stabilization platform technology and have received government funding support from agencies including the National Institute of Allergy and Infectious Diseases, the Defense Threat Reduction Agency, and the Biomedical Advanced Research and Development Authority. Further information about Soligenix developments is available through the company's newsroom at https://ibn.fm/SNGX.
The publication of these Phase 2a results represents a significant milestone in Behçet's Disease treatment research, potentially offering patients a new therapeutic option with favorable safety and efficacy profiles. As Soligenix advances SGX945 development and explores broader applications for its innate defense regulator technology, the implications extend beyond Behçet's Disease to multiple inflammatory conditions with limited treatment options. The company's progress highlights ongoing innovation in addressing rare disease therapeutic challenges through targeted biopharmaceutical development.
