What is the story about?
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 Phase 3 study of HyBryte™ in treating cutaneous T-cell lymphoma (CTCL). The expanded board includes esteemed dermatologists Drs. Scarisbrick and Vermeer, who will provide critical input on clinical strategies and regulatory interactions. The study aims to enroll approximately 80 patients and report top-line results in 2026. HyBryte™, a novel photodynamic therapy, utilizes synthetic hypericin activated by visible light to treat CTCL, offering a safer alternative to current therapies.
Why It's Important?
The expansion of the European MAB is crucial for Soligenix as it seeks marketing approvals in Europe for HyBryte™. CTCL is a rare form of non-Hodgkin's lymphoma with limited treatment options, and HyBryte™ represents a potentially safer and effective therapy. The involvement of European experts is expected to facilitate the approval process in the EU and UK, addressing the unmet medical needs of CTCL patients. Successful commercialization of HyBryte™ could significantly impact the treatment landscape for CTCL, offering a new front-line therapy option.
What's Next?
Soligenix plans to continue working with the expanded MAB to advance HyBryte™ towards commercialization. The company anticipates reporting top-line results from the Phase 3 study in 2026, which will be pivotal for regulatory approval. Discussions with health authorities will be ongoing to ensure the study meets all necessary requirements for marketing authorization. The company is also exploring the expansion of HyBryte™ into other indications, such as psoriasis, leveraging its proprietary technology.
AI Generated Content
Do you find this article useful?
