Soligenix, Inc. (Nasdaq: SNGX) has announced the formation of a European Medical Advisory Board (MAB) to provide strategic guidance for its upcoming Phase 3 clinical trial of HyBryte™ (synthetic hypericin) in patients with early-stage cutaneous T-cell lymphoma (CTCL). The multicenter, double-blind, placebo-controlled study is set to begin enrolling patients by the end of 2024, with topline results anticipated in the second half of 2026. This initiative underscores Soligenix's commitment to advancing treatments for rare diseases with unmet medical needs.
European Medical Advisory Board
The European MAB comprises internationally recognized physicians with extensive experience in CTCL treatment and clinical research. Members include:
- Martine Bagot, MD, PhD (France): Professor and Head of the Department of Dermatology at Hôpital Saint Louis in Paris.
- Pietro Quaglino, MD (Italy): Associate Professor of Dermatology at the Department of Medical Sciences, University of Turin Medical School.
- Pablo Luis Ortiz-Romero, MD, PhD (Spain): Professor of Dermatology and Head of the Dermatology Department at Hospital Universitario 12 de Octubre.
This esteemed board will provide feedback and guidance on clinical strategies, regulatory interactions, health economics, and reimbursement to support Soligenix in addressing the needs of CTCL patients.
HyBryte™ Phase 3 Clinical Trial
The confirmatory Phase 3 study will enroll approximately 80 patients in the U.S. and Europe. The trial aims to evaluate the safety and efficacy of HyBryte™ over an 18-week period. This study, known as FLASH2, replicates the double-blind, placebo-controlled design of the first successful Phase 3 FLASH study but extends the double-blind assessment to 18 weeks of continuous treatment.
Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix, stated, "Stemming from the positive feedback from the European Medicines Agency (EMA) on the key design components of our confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™, we consider expert European involvement a necessary component for the development of this program."
About HyBryte™
HyBryte™ (SGX301) is a first-in-class photodynamic therapy that uses safe, visible light for activation. The active ingredient, synthetic hypericin, is applied topically to skin lesions and activated by visible light approximately 24 hours later. In a published Phase 3 FLASH trial, 16% of patients receiving HyBryte™ achieved at least a 50% reduction in their lesions compared to 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle.
HyBryte™ has received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA) and orphan designation from the European Medicines Agency (EMA).
Cutaneous T-Cell Lymphoma (CTCL) Overview
CTCL is a rare type of non-Hodgkin's lymphoma affecting T-cell lymphocytes, which migrate to the skin and form lesions. It is estimated to affect approximately 31,000 individuals in the U.S. and 38,000 in Europe. While there is no cure for CTCL, treatments aim to manage symptoms and lesion regression. The severity of CTCL impacts survival rates, ranging from approximately 12 years in early stages to 2.5 years in advanced stages.
