Soligenix has reported positive data from its Phase IIa trial of SGX945 (dusquetide) for the treatment of Behçet’s disease.
The proof-of-concept study examined SGX945 for treating oral ulcers in the illness.
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It reported that seven of eight patients experienced beneficial effects over four weeks of treatment, with potential enduring benefits observed during the subsequent four-week follow-up.
The open-label study used the Phase III trial of apremilast (Otezla) as a baseline.
It indicated that SGX945’s outcomes in terms of area under the curve (AUC), average oral ulcers, and pain improvement were comparable.
Outcomes from weeks five to eight remained comparable, even though apremilast dosing continued throughout this interval while SGX945 was discontinued after week four in accordance with the study protocol.
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By GlobalDataUsing the primary endpoint from the Phase III apremilast study, the AUC of the mean ulcer number versus time, SGX945 demonstrated a 40% improvement over placebo after four weeks, compared to 37% for apremilast.
This effect was sustained at 32% at week eight, despite SGX945 discontinuation at week four, while apremilast had 41% improvement at week eight.
SGX945 was found to be well-tolerated with no treatment-related adverse events, while apremilast was associated with headache, diarrhoea, and nausea.
These results were published in Rheumatology via Oxford Academic, in an article entitled ‘Results from a Pilot Study of Dusquetide for the Treatment of Aphthous Ulcers Associated with Behçet Syndrome’.
Soligenix president and CEO Christopher Schaber said: “We are pleased to publish the data from our recent SGX945 Phase IIa trial in aphthous ulcers of Behçet’s disease, enabling the medical community to evaluate this novel mechanism and therapeutic.
“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.”
In December 2024, Soligenix started enrolling subjects in its double-blind, multi-centre Phase III trial of HyBryte (synthetic hypericin), a first-in-class photodynamic therapy for cutaneous T-cell lymphoma (CTCL).
