Soligenix receives UK medicine designation for Behcet's disease drug

Soligenix Inc. (NASDAQ: SNGX) announced that its drug SGX945 has received Promising Innovative Medicine designation from the UK Medicines and Healthcare Products Regulatory Agency for treating Behçet's Disease.

The designation represents the first step toward potential inclusion in the UK Early Access to Medicines Scheme, which allows patients with life-threatening conditions to access experimental treatments before standard approval. The MHRA grants this designation to medicines that meet three criteria: addressing conditions with high unmet medical need, offering major advantages over current treatments, and demonstrating benefits that likely outweigh potential risks.

"We are excited that the MHRA agrees that dusquetide meets the specified criteria for PIM designation based on the Phase 2 clinical data in Behçet's Disease," said Christopher J. Schaber, Soligenix's president and chief executive officer.

SGX945 contains dusquetide, a synthetic peptide that modulates immune system responses toward anti-inflammatory and tissue healing effects. The drug previously received Fast-Track designation from the FDA for treating oral lesions of Behçet's Disease and Orphan Drug designation for the condition. The European Medicines Agency also provided a positive opinion on Orphan Drug Designation for SGX945.

In a Phase 2a study involving eight patients with Behçet's Disease, SGX945 demonstrated a 40% improvement in ulcer reduction compared to placebo data from a separate apremilast study. The improvement sustained through a four-week follow-up period after treatment ended. No treatment-related adverse events occurred during the trial.

Behçet's Disease affects approximately 18,000 people in the United States and over 50,000 in Europe. The inflammatory condition commonly causes mouth sores, skin lesions, and genital ulcers. Currently, apremilast represents the only approved drug specifically for Behçet's Disease oral ulcers.

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