Soligenix Expands European Medical Advisory Board to Advance CTCL Treatment Development

Soligenix is strengthening its European medical advisory board and advancing Phase 3 clinical trials for HyBryte, a potential new treatment for cutaneous T-cell lymphoma that addresses significant unmet medical needs in European patients.

October 9, 2025
Soligenix Expands European Medical Advisory Board to Advance CTCL Treatment Development

Soligenix Inc. has expanded its European Medical Advisory Board to provide additional clinical and strategic guidance as the company advances its confirmatory Phase 3 study evaluating the safety and efficacy of HyBryte for treating cutaneous T-cell lymphoma. The expansion underscores the company's commitment to delivering innovative treatment options to European patients facing this rare but serious form of non-Hodgkin lymphoma.

Cutaneous T-cell lymphoma primarily affects the skin and represents a substantial unmet medical need, particularly for early-stage patients who often have limited treatment options. Globally, millions suffer from CTCL, with European incidence rates estimated at 2.9 to 3.9 cases per million people annually according to epidemiological data available at https://ibn.fm/ANk8X. This rarity makes developing effective treatments particularly challenging yet critically important for affected patients.

The company's FLASH2 Phase 3 study represents a significant step toward establishing HyBryte as a potential new standard of care. HyBryte is a first-in-class photodynamic therapy using synthetic hypericin as a photosensitizer, offering a novel approach to treating this difficult condition. The expanded European Medical Advisory Board, detailed in the company's announcement at https://ibn.fm/6354Y, will play a crucial role in guiding the clinical development strategy and helping navigate complex regulatory requirements across European markets.

This strategic expansion comes at a pivotal time for CTCL treatment development in Europe. The medical advisory board's enhanced expertise will support the successful execution of the FLASH2 study and ensure that European patient needs are adequately represented in the treatment's development pathway. For patients currently facing limited therapeutic options, the advancement of HyBryte through clinical trials offers hope for a new, effective treatment modality that could significantly improve quality of life and disease management.

The company's focused approach to addressing this rare disease demonstrates the importance of targeted pharmaceutical development for conditions that affect smaller patient populations. By strengthening its European medical guidance and advancing clinical trials, Soligenix is positioning HyBryte as a potential breakthrough therapy for CTCL patients who have long awaited new treatment options that are both effective and well-tolerated.