Soligenix expands European Medical Advisory Board for HyBryte clinical study.

Soligenix has expanded its European Medical Advisory Board to provide strategic guidance as the company advances its Phase 3 study evaluating the safety and efficacy of HyBryte in treating cutaneous T-cell lymphoma. The study, expected to enroll 80 patients, is targeted to report top-line results in the second half of 2026.

Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company, has announced the expansion of its European Medical Advisory Board (MAB) to provide strategic guidance as it advances its Phase 3 study evaluating the safety and efficacy of HyBryte™ in treating cutaneous T-cell lymphoma (CTCL). The company aims to enroll approximately 80 patients in this confirmatory study, which is expected to report top-line results in the second half of 2026 Soligenix Announces Expansion of European Medical Advisory Board for Cutaneous T-Cell Lymphoma^[1].

The expanded European MAB now includes five members: Dr. Martine Bagot (France), Dr. Pietro Quaglino (Italy), Dr. Pablo Luis Ortiz-Romero (Spain), Dr. Julia Scarisbrick (United Kingdom), and Dr. Maarten H. Vermeer (The Netherlands). These esteemed dermatologists bring extensive clinical experience and expertise in CTCL to the board, which will play a crucial role in the conduct and interpretation of the Phase 3 clinical study and regulatory interactions with health authorities Soligenix Announces Expansion of European Medical Advisory Board for Cutaneous T-Cell Lymphoma^[1].

The MAB will provide valuable feedback and input on clinical strategies, health economics, and reimbursement, helping Soligenix meet the needs of patients suffering from CTCL. This expansion underscores Soligenix's commitment to expert European involvement in the development and approval of HyBryte™ in both the European Union (EU) and the United Kingdom (UK) Soligenix Announces Expansion of European Medical Advisory Board for Cutaneous T-Cell Lymphoma^[1].

HyBryte™ is a novel photodynamic therapy utilizing safe, visible light for activation. The active ingredient, synthetic hypericin, has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study, patients experienced a statistically significant improvement with topical hypericin treatment compared to placebo Soligenix Announces Expansion of European Medical Advisory Board for Cutaneous T-Cell Lymphoma^[1].

Soligenix's Phase 3 study follows the success of its Phase 2 FLASH trial, which enrolled 169 patients with Stage IA, IB, or IIA CTCL. The trial demonstrated a 16% response rate in the first treatment cycle and a 40% response rate in the second cycle, with continued treatment resulting in better outcomes Soligenix Announces Expansion of European Medical Advisory Board for Cutaneous T-Cell Lymphoma^[1].