Soligenix, Inc. 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 approximately 80 patients in the United States and Europe by the end of 2024, with top-line 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 newly formed MAB consists of internationally recognized physicians with extensive experience in CTCL clinical research and treatment. 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 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 expert panel will advise Soligenix on clinical strategies, regulatory interactions, and health economics to support the development and potential commercialization of HyBryte™ in Europe.
HyBryte™ Phase 3 Trial
The Phase 3 trial, a confirmatory study following positive feedback from the European Medicines Agency (EMA), aims to evaluate the safety and efficacy of HyBryte™ in early-stage CTCL. The trial design replicates the double-blind, placebo-controlled approach of the first Phase 3 FLASH study. The FLASH trial enrolled 169 patients with Stage IA, IB, or IIA CTCL and demonstrated that 16% of patients receiving HyBryte™ achieved at least a 50% reduction in their lesions compared to 4% in the placebo group at 8 weeks (p=0.04).
This second study extends the double-blind, placebo-controlled assessment to 18 weeks of continuous treatment with a more aggressive titration of the light doses. The primary endpoint assessment occurring at the end of the 18-week timepoint. In the first Phase 3 study, a treatment response of 49% (p<0.0001 vs patients receiving placebo in Cycle 1) was observed in patients completing 18 weeks (3 cycles) of therapy.
About HyBryte™
HyBryte™ (SGX301) is a first-in-class photodynamic therapy that uses a topical application of synthetic hypericin, a potent photosensitizer, followed by activation with safe, visible light. This approach targets malignant T-cells in the skin while minimizing the risk of secondary malignancies associated with DNA-damaging drugs and ultraviolet light exposure. In a Phase 2 clinical study, topical hypericin treatment resulted in a statistically significant improvement (p=0.04) compared to placebo.
HyBryte™ has received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA) and orphan designation from the EMA.
Cutaneous T-Cell Lymphoma (CTCL)
CTCL is a rare form of non-Hodgkin's lymphoma affecting T-cell lymphocytes that migrate to the skin, causing lesions, plaques, and tumors. It affects 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 improve quality of life. Soligenix is dedicated to addressing the unmet needs of CTCL patients through the development of innovative therapies like HyBryte™.
