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 that year. This milestone represents significant progress for patients suffering from this rare form of cancer who currently have limited treatment 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 that HyBryte may demonstrate stronger efficacy than initially projected, potentially offering new hope for CTCL patients who have failed other therapies. The full details of the study and additional data can be found in the company's official press release at https://ibn.fm/zuCdx.

Investigators have reported safety findings consistent with earlier studies, with HyBryte continuing to demonstrate encouraging efficacy signals across the ongoing development program. The treatment represents a novel photodynamic therapy utilizing safe visible light, distinguishing it from other available treatments that may carry more significant side effects. This safety profile is particularly important for CTCL patients who often require long-term treatment management.

Cutaneous T-cell lymphoma is a rare type of cancer that begins in white blood cells called T cells and primarily affects the skin. Patients with this condition often experience significant quality of life impacts due to visible skin lesions, itching, and discomfort. The completion of enrollment for this interim analysis brings the medical community closer to potentially having a new, effective treatment option that could address unmet medical needs in this patient population.

The successful completion of this Phase 3 study could lead to regulatory approvals supporting potential commercialization worldwide. For investors and the biopharmaceutical industry, this development represents progress in Soligenix's Specialized BioTherapeutics business segment, which focuses on developing treatments for rare diseases with limited therapeutic options. Additional information about the company's developments and news updates is available at https://ibn.fm/SNGX.

This advancement in CTCL treatment research highlights the ongoing importance of developing targeted therapies for rare diseases that often receive less attention from larger pharmaceutical companies. The positive efficacy signals and consistent safety profile observed to date suggest that HyBryte could become an important addition to the treatment landscape for cutaneous T-cell lymphoma patients worldwide.