What's Happening?
Soligenix, a biopharmaceutical company, has expanded its European Medical Advisory Board (MAB) to support the Phase 3 study of HyBryte™, a treatment for cutaneous T-cell lymphoma (CTCL). The expanded board includes renowned dermatologists who will provide strategic guidance for the study, which aims to evaluate the safety and efficacy of HyBryte™. The study is expected to enroll 80 patients and report results in 2026. This expansion is part of Soligenix's efforts to secure marketing approvals in Europe.
Why It's Important?
CTCL is a rare form of non-Hodgkin's lymphoma with limited treatment options. The expansion of the MAB signifies Soligenix's commitment to advancing HyBryte™ towards commercialization, potentially offering a new treatment option for CTCL patients. The involvement of European experts is crucial for navigating regulatory processes and ensuring the study's success. If successful, HyBryte™ could address an unmet medical need, improving outcomes for patients with early-stage CTCL.
What's Next?
The Phase 3 study will continue, with top-line results expected in 2026. Soligenix will work closely with the MAB to ensure the study meets regulatory requirements and advances towards commercialization. The company may also explore additional applications for HyBryte™ in other dermatological conditions, potentially expanding its market reach.
