Following the release of positive trial data, shares of Soligenix, Inc. (NASDAQ: SNGX) saw a significant increase in value. SNGX’s stock was up 95.20% at $2.44 as of the most recent trading. The spike comes after the company revealed that the major effectiveness goals of its Phase 2a proof-of-concept study for SGX945 (dusquetide) in treating Behçet’s disease were met.
Phase 2a Research Shows Efficacy on Par with Authorized Therapy
The Phase 3 study of apremilast (Otezla), which supports its marketing approval for oral ulcers in Behçet’s disease, was closely modeled by the Phase 2a open-label experiment. The results of SGX945 were compared to the apremilast and placebo groups of that Phase 3 trial.
Over the course of four weeks, SGX945 showed improvements in oral pain and ulcer count that were equivalent to those seen with apremilast. Interestingly, effectiveness continued through Weeks 5–8, almost matching continuous apremilast therapy throughout the same time frame, even though SGX945 medication ended at Week 4.
Sustained Benefits Beyond Treatment Period
Using the same primary endpoint—area under the curve (AUC) for mean ulcer count over time—SGX945 achieved a 40% improvement versus placebo, compared to 37% for apremilast. At Week 8, four weeks post-treatment, SGX945 maintained a 32% improvement, while apremilast, administered through Week 12, recorded a 41% improvement.
Seven of eight patients reported symptom relief, including shorter ulcer duration, fewer occurrences, and reduced pain. A skin ulcer in one patient, typically difficult to treat, resolved during the study. SGX945 was well tolerated, with no treatment-related adverse events reported.
Future Development and Market Potential
Soligenix plans to reformulate SGX945 for home-based administration via subcutaneous injection, potentially supporting chronic or maintenance use. SNGX is to progress the development of dusquetide for Behçet’s Disease and other inflammatory illnesses linked to the innate immune system.
Behçet’s disease is a major unmet medical need, with an estimated 18,000 people in the United States, 50,000 in Europe, 350,000 in Turkey, and up to 1 million worldwide. SGX945 may become a competitive option to existing treatments given the effectiveness, longevity, and tolerability seen, especially for individuals with severe or chronic ulcers.
