SNGX News & Events

Soligenix announced that SGX945 has been granted Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency for the treatment of Behcet's Disease.

Soligenix announced that the European Medicines Agency Committee for Orphan Medicinal Products provided a positive recommendation on the company's request for orphan drug designation for dusquetide for the treatment of Behcet's Disease, following review of the recently published Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behcet's Disease. The next step in the process will be ratification of the positive opinion by the European Commission. SGX945 has previously been granted both orphan drug and fast track designations from the US FDA for the treatment of Behcet's Disease.

Soligenix announced that the results from its Phase 2a proof of concept study evaluating SGX945, or dusquetide, in the treatment of Behcet's Disease have been published in Rheumatology (Oxford). The Phase 2a study, evaluating control of oral ulcers in Behcet's Disease, reported beneficial effects for 7 of 8 patients, over the 4 weeks of treatment as well as a potentially enduring effect through the 4 weeks of follow-up. Using the Phase 3 study of apremilast as a baseline for comparison, this open-label study indicated that the area under the curve, average number of oral ulcers, and improvements in oral pain for SGX945 were similar to outcomes obtained in the apremilast study. Notably, outcomes in weeks 5 through 8 continued to show similar outcomes, even though apremilast treatment was continued through this period whereas SGX945 treatment was stopped at Week 4, per study design. SGX945 was well-tolerated with no treatment-related adverse events. Common adverse events for apremilast included diarrhea - 41% of patients -, nausea - 19% of patients - and headache - 14% of patients -, none of which were observed with SGX945.

Soligenix announced extended results of its ongoing Phase 2a trial of SGX302, or synthetic hypericin, for the treatment of mild-to-moderate psoriasis. In this extension, or Cohort 3, of the exploratory phase of the study, an additional four patients were enrolled and treated with an improved topical gel formulation of synthetic hypericin. The Cohort 3 patients were treated for the same 18-week period as Cohorts 1 and 2, but utilized an optimized gel formulation of synthetic hypericin. The gel formulation was specifically designed to improve ease of application to larger areas of the skin. SGX302 gel therapy was well tolerated by all patients with no drug related adverse events identified. On average over the three evaluable patients, there were improvements in the Investigator Global Assessment, or IGA, the Psoriasis Activity and Severity Index, or PASI, the simplified psoriasis index, the dermatology life quality index and the Skindex-29 questionnaire. One patient achieved a disease status of "Almost Clear" using the IGA, which is considered a standard clinical measure for treatment success in psoriasis, with a substantial improvement in their PASI score, exceeding 50%. These outcomes were very similar to or improved relative to those obtained with the previous ointment formulation, as expected given the comparable release characteristics of the two formulations and the enhanced ease of application of the gel. In totality, the initial exploratory phase of the study has confirmed that SGX302 improves psoriasis lesions, consistent with the general success of photodynamic therapies in psoriasis, and is well tolerated, potentially providing a non-carcinogenic, non-mutagenic treatment for the thicker lesions found in psoriasis.