Soligenix Completes Enrollment for Interim Analysis in Phase 3 FLASH2 Study of HyBryte for Cutaneous T-Cell Lymphoma

Soligenix Inc. has completed enrollment of the 50 patients required for the interim analysis in its 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 the year. This milestone represents significant progress in the development of a novel treatment for this rare form of 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 response rate suggests potentially 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.

HyBryte represents a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. The treatment approach differs from conventional therapies by using synthetic hypericin sodium activated by visible light, potentially offering patients a safer alternative with fewer side effects compared to existing treatments. The successful completion of this second Phase 3 study could support regulatory approvals for commercialization worldwide, addressing a significant unmet medical need in the rare disease space.

The implications of this development extend beyond the immediate patient population. Successful commercialization of HyBryte could establish a new standard of care for cutaneous T-cell lymphoma patients and demonstrate the viability of photodynamic therapies in oncology. The company's broader development program includes expansion of synthetic hypericin into psoriasis treatment and other inflammatory conditions, suggesting potential applications across multiple therapeutic areas. Additional information about the company's development programs is available at https://ibn.fm/SNGX.

For patients with cutaneous T-cell lymphoma, the progress in HyBryte's development offers hope for a new treatment option that combines efficacy with a favorable safety profile. The rare nature of this condition means that treatment advancements can significantly impact quality of life for affected individuals. The biotechnology sector closely watches such developments as they represent potential breakthroughs in addressing difficult-to-treat conditions and demonstrate the continued innovation in targeted cancer therapies.