Soligenix Reports Positive Phase 2a Results for SGX945 in Behçet's Disease Treatment
TL;DR
Soligenix's SGX945 shows comparable efficacy to apremilast with only four weeks of dosing, offering a potential competitive advantage in treating Behçet's Disease ulcers.
SGX945 demonstrated beneficial effects in seven of eight patients with sustained improvement through a four-week follow-up after treatment ended, with no treatment-related adverse events observed.
This treatment could significantly improve quality of life for Behçet's Disease patients by reducing oral ulcers and pain while addressing an unmet medical need.
Soligenix's novel drug SGX945 achieved results comparable to an established Phase 3 treatment with just four weeks of dosing instead of continuous administration.
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Soligenix Inc. announced that results from its Phase 2a proof-of-concept study evaluating SGX945 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. This distinction suggests SGX945 could offer a treatment advantage with a finite dosing period rather than ongoing therapy, potentially improving patient compliance and reducing long-term medication burden.
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. The company's Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte(TM) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, with development programs also including expansion of synthetic hypericin into psoriasis and dusquetide for the treatment of inflammatory diseases. These parallel developments indicate a strategic focus on immune-mediated conditions with limited treatment options.
The Public Health Solutions business segment includes development programs for RiVax(R), the company's ricin toxin vaccine candidate, as well as vaccine programs targeting filoviruses and CiVax(TM), a vaccine candidate for the prevention of COVID-19. The development of these vaccine programs incorporates the use of proprietary heat stabilization platform technology known as ThermoVax(R). This business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases, the Defense Threat Reduction Agency and the Biomedical Advanced Research and Development Authority. The latest news and updates relating to Soligenix are available in the company's newsroom at https://ibn.fm/SNGX.
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