Soligenix's HyBryte Therapy Shows Positive Safety Profile in Phase 3 CTCL Trial

Soligenix Inc. has received a positive safety review from its Data Monitoring Committee for the ongoing confirmatory Phase 3 FLASH2 study of HyBryte in cutaneous T-cell lymphoma. The committee concluded there are no safety concerns and that the therapy maintains an acceptable safety profile consistent with prior trials, providing important validation for the treatment's development pathway.

The FLASH2 trial represents a critical step in Soligenix's efforts to bring HyBryte to market as a potential first-line treatment option for early-stage CTCL. The study builds on the company's earlier statistically significant Phase 3 results and additional supportive studies that have demonstrated HyBryte's efficacy and tolerability. Enrollment in the current trial is progressing on schedule, with an update expected in the fourth quarter of 2025 and a blinded interim efficacy analysis planned for the first half of 2026.

For patients suffering from cutaneous T-cell lymphoma, this development represents significant progress toward a new treatment option. CTCL is a rare type of cancer that begins in white blood cells called T cells and primarily affects the skin, causing rash-like patches, plaques, or tumors. Current treatment options are limited, and the potential approval of HyBryte could provide patients with a novel therapeutic approach that combines synthetic hypericin with safe visible light in a photodynamic therapy.

The positive safety review from the independent Data Monitoring Committee provides important reassurance about the therapy's risk profile as it advances through clinical development. This milestone is particularly significant given that safety concerns often derail promising drug candidates during late-stage trials. The committee's endorsement suggests HyBryte continues to demonstrate the favorable safety characteristics observed in earlier studies.

Soligenix's progress with HyBryte represents an important development in the rare disease treatment landscape. The company has indicated that with successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. This could make HyBryte available to CTCL patients globally who currently have limited treatment options. Additional information about Soligenix's development programs is available in the company's newsroom.

The broader implications of this development extend beyond CTCL treatment alone. Soligenix is also exploring expansion of synthetic hypericin into psoriasis treatment, suggesting the technology platform could have applications across multiple dermatological conditions. The company's progress with HyBryte demonstrates the ongoing innovation in photodynamic therapies and their potential to provide new treatment options for patients with limited alternatives.