Soligenix Completes Enrollment for Interim Analysis in Phase 3 FLASH2 Study of HyBryte

Soligenix Inc. has completed enrollment of the 50 patients required for the interim analysis in its 80-patient confirmatory Phase 3 FLASH2 study evaluating HyBryte in cutaneous T-cell lymphoma. The interim analysis is scheduled for the second quarter of 2026, with topline data expected in the second half of that year. This milestone represents significant progress in the development of a novel treatment for this rare cancer that currently has limited therapeutic options.

The company reported an overall blinded response rate of 48 percent among patients who have completed treatment to date, substantially exceeding the anticipated 25 percent rate used in the study's powering assumptions. This higher-than-expected response rate suggests stronger efficacy than initially projected for the photodynamic therapy treatment. Investigators have noted safety findings consistent with earlier studies, with HyBryte continuing to demonstrate encouraging efficacy signals across the ongoing development program.

Successful completion of this second Phase 3 study will support regulatory approvals sought for potential commercialization worldwide. The development represents an important advancement for patients with cutaneous T-cell lymphoma, a rare disease with significant unmet medical needs. The company's progress can be followed through updates available in their newsroom at https://ibn.fm/SNGX.

The FLASH2 study builds upon previous clinical research and represents a critical step toward bringing a new treatment option to market. Cutaneous T-cell lymphoma patients often face limited therapeutic choices, making the development of novel treatments like HyBryte particularly significant. The photodynamic therapy approach utilizing safe visible light represents an innovative mechanism of action compared to existing treatments.

With the interim analysis now scheduled and patient enrollment complete for this phase, the study moves closer to potentially providing meaningful clinical data that could support regulatory submissions. The higher response rate observed to date suggests the treatment may offer substantial benefit to patients suffering from this challenging condition. Further details about the study and company developments are available through the full press release at https://ibn.fm/uxz52.