Soligenix has reported new clinical momentum for its lead innate immune modulator SGX945 (dusquetide), announcing that positive Phase 2a results in Behçet’s Disease have been published in Rheumatology (Oxford). 

 

The peer-reviewed article, titled “Results from a Pilot Study of Dusquetide for the Treatment of Aphthous Ulcers Associated with Behçet Syndrome,” highlights meaningful clinical benefits in a disease with few durable treatment options.

 

In the open-label proof-of-concept study, SGX945 delivered beneficial effects in 7 of 8 patients suffering from painful oral ulcers, the hallmark symptom of Behçet’s Disease. Improvements were seen during the four-week treatment period and, notably, persisted through a four-week follow-up after dosing stopped—an outcome that sets SGX945 apart from many current therapies.

 

Using outcomes from the Phase 3 apremilast (Otezla) study as a benchmark, SGX945 demonstrated comparable performance across key measures, including area under the curve (AUC), average number of oral ulcers, and oral pain reduction. While apremilast required continuous dosing, SGX945 maintained similar benefits even after treatment ended at Week 4, underscoring a potentially durable therapeutic effect.

 

Patient-reported outcomes reinforced the numerical data. Most participants experienced fewer ulcers, shorter ulcer duration, and less oral pain. One patient with a punctuated skin ulcer—a manifestation typically resistant to treatment—saw complete resolution during the four-week SGX945 regimen. Some patients also reported continued improvement during the follow-up period.

 

Equally notable was SGX945’s safety profile. The drug was well tolerated, with no treatment-related adverse events reported. Common side effects associated with apremilast, including diarrhea, nausea, and headache, were not observed in patients receiving SGX945.

 

“We are pleased to publish the data from our recent SGX945 Phase 2a trial in aphthous ulcers of Behçet's Disease, enabling the medical community to evaluate this novel mechanism and therapeutic,” stated Christopher J. Schaber, President and Chief Executive Officer of Soligenix. 

 

“Given the role of the innate immune system, we believe that dusquetide may offer significant relief to patients. With these, now published, results, we intend to embark on a reformulation of SGX945 to enable home-based treatment, using subcutaneous injection as used for example with weight-loss drugs. 

 

"We are excited to expand dusquetide's development into different innate immune-related inflammatory conditions, such as Behçet's Disease, as a component of our long-term strategy to enhance the value of this unique compound. 

 

"Behçet's Disease is an area of unmet medical need, with up to 18,000 people in the U.S., 50,000 in Europe, 350,000 people in Turkey and as many as 1 million people worldwide affected by this incurable and chronic disease. We look forward to undertaking reformulation and interacting with the health authorities in designing a follow-on clinical study.”

 

With peer-reviewed validation now in hand, Soligenix is positioning SGX945 for next-stage development as it targets a global patient population with limited and imperfect treatment options.