Soligenix Inc. (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). The study reported beneficial effects in seven of eight patients with sustained improvement through a four-week follow-up period after treatment ended.
The company noted that 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), despite SGX945 dosing stopping at Week 4 while apremilast required continuous administration. SGX945 was well tolerated with no treatment-related adverse events observed.
Soligenix 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. The full press release is available at https://ibn.fm/ibHfU.
Behçet’s Disease is a chronic, relapsing systemic vasculitis characterized by recurrent oral and genital ulcers, skin lesions, and ocular inflammation. Current treatments often require continuous dosing and can have significant side effects. Dusquetide, a first-in-class innate defense regulator (IDR) technology, aims to modulate the innate immune response to reduce inflammation and promote healing.
The positive Phase 2a data suggest that SGX945 could offer a more convenient treatment option with a shorter dosing regimen, potentially improving patient compliance and quality of life. The comparable efficacy to apremilast, which is approved for Behçet’s Disease, underscores the potential of dusquetide as a novel therapeutic approach.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases with unmet medical needs. Its Specialized BioTherapeutics business segment includes dusquetide (SGX942) for inflammatory diseases like oral mucositis in head and neck cancer and SGX945 for Behçet’s Disease. The company also has a Public Health Solutions segment developing vaccines against ricin, filoviruses, and COVID-19 using its ThermoVax heat stabilization platform.
For more information about Soligenix and its pipeline, visit the company’s newsroom at https://ibn.fm/SNGX.
