Soligenix expands European medical board for lymphoma drug approval push

Soligenix Inc. (NASDAQ: SNGX) announced the expansion of its European Medical Advisory Board to include five physicians specializing in cutaneous T-cell lymphoma treatment. The Princeton, New Jersey-based biopharmaceutical company added Drs. Julia Scarisbrick from the United Kingdom and Maarten H. Vermeer from The Netherlands to the board.

The expanded advisory board will provide guidance as Soligenix advances its confirmatory Phase 3 study of HyBryte, a photodynamic therapy for treating early-stage cutaneous T-cell lymphoma. The 18-week study plans to enroll approximately 80 patients and expects to report results in the second half of 2026.

The five-member board includes internationally recognized dermatologists with extensive experience in cutaneous T-cell lymphoma clinical research. Existing members are Dr. Martine Bagot from France, Dr. Pietro Quaglino from Italy, and Dr. Pablo Luis Ortiz-Romero from Spain.

HyBryte uses synthetic hypericin applied topically to skin lesions, which is activated by visible light approximately 24 hours later. The treatment has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency.

A previous Phase 3 trial showed 16% of patients receiving HyBryte achieved at least a 50% reduction in lesions compared to 4% in the placebo group at 8 weeks. Extended treatment for 12 weeks showed a 40% response rate.

The FDA and European Medicines Agency have indicated they require a second successful Phase 3 trial to support marketing approval. The current confirmatory study replicates the design of the first trial but extends treatment to a continuous 18 weeks with the primary endpoint assessment at the end of that period.

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