Soligenix Publishes Phase 2a Results for SGX945 in Behçet’s Disease

SNGX
December 18, 2025

Soligenix, Inc. (NASDAQ: SNGX) published the results of its Phase 2a, open‑label study of the innate‑defense regulator dusquetide (SGX945) in patients with Behçet’s disease in the journal Rheumatology (Oxford) on December 18, 2025. The study, which enrolled eight patients, demonstrated that seven of the eight participants experienced meaningful improvement in oral ulcer control during the four‑week treatment period, with a sustained effect observed through a four‑week follow‑up.

The investigators reported that the area‑under‑the‑curve (AUC) for ulcer number and time to resolution was comparable to outcomes seen with the approved drug apremilast. SGX945 achieved a 40 % improvement relative to the placebo group from the apremilast Phase 3 RELIEF trial, and a 32 % improvement at week 8 after treatment cessation. No treatment‑related adverse events were observed, underscoring the favorable safety profile of the peptide.

Soligenix’s CEO Christopher J. Schaber highlighted the significance of the data, noting that the publication confirms the therapeutic potential of dusquetide and supports the company’s plan to reformulate the drug for home‑based subcutaneous injection. The company also reiterated its Orphan Drug Designation and Fast Track status for SGX945, positioning the candidate for accelerated regulatory review and potential market entry in a disease with limited treatment options.

Investors reacted positively to the announcement, reflecting confidence in the clinical milestone and the strategic shift toward patient‑friendly delivery. The publication adds credibility to SGX945’s development trajectory and reinforces its potential commercial value within Soligenix’s rare‑disease pipeline.

Beyond Behçet’s disease, Soligenix continues to advance other programs, including HyBryte™ for cutaneous T‑cell lymphoma and SGX302 for psoriasis, while pursuing further clinical development of SGX945 in additional inflammatory conditions. The Phase 2a results strengthen the company’s portfolio and support its broader strategy of expanding access to innovative, well‑tolerated therapies.

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