What's Happening?
Soligenix, Inc., a late-stage biopharmaceutical company, has announced the expansion of its European Medical Advisory Board (MAB) to enhance strategic guidance for its ongoing Phase 3 study of HyBryte™. This study focuses on the treatment of cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin's lymphoma. The expanded MAB includes esteemed dermatologists Drs. Scarisbrick and Vermeer, who will provide critical insights as Soligenix seeks marketing approvals in Europe. The confirmatory Phase 3 study is a multicenter, double-blind, placebo-controlled trial expected to enroll approximately 80 patients, with results anticipated in the second half of 2026. HyBryte™ utilizes synthetic hypericin activated by visible light, offering a novel approach to treating CTCL without the risks associated with ultraviolet light therapies.
Why It's Important?
The expansion of the MAB is significant as it strengthens Soligenix's position in the European market, potentially accelerating the approval and commercialization of HyBryte™. CTCL is a challenging condition with limited treatment options, and HyBryte™ offers a safer alternative to existing therapies that carry risks of secondary malignancies. The involvement of renowned European experts underscores the importance of international collaboration in advancing treatment options for rare diseases. Successful commercialization of HyBryte™ could provide a new frontline therapy for CTCL, benefiting patients who currently have limited options and face significant health risks.
What's Next?
Soligenix plans to continue its engagement with health authorities in Europe and the United States to secure necessary approvals for HyBryte™. The company will focus on completing the Phase 3 study and reporting top-line results by 2026. Ongoing discussions with the FDA may lead to modifications in the study design to address regulatory feedback. The expanded MAB will play a crucial role in guiding these interactions and ensuring that the study meets the rigorous standards required for approval. Soligenix's strategic focus will also include exploring additional applications of HyBryte™ and expanding its use in other dermatological conditions.
