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

Soligenix Inc. has reached a significant milestone in its clinical development program, completing 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 development represents a crucial step forward for patients suffering from this rare form of cancer who currently face 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 strong performance suggests HyBryte may offer meaningful clinical benefits for cutaneous T-cell lymphoma patients. Investigators have noted safety findings consistent with earlier studies, with HyBryte continuing to demonstrate encouraging efficacy signals across the ongoing development program. The complete press release detailing these developments is available at https://ibn.fm/zuCdx.

HyBryte represents a novel photodynamic therapy approach that utilizes safe visible light for treating cutaneous T-cell lymphoma. The therapy's mechanism involves synthetic hypericin sodium, which is activated by visible light to target malignant T-cells while minimizing damage to healthy tissue. This targeted approach could potentially offer advantages over existing treatments that often cause significant side effects. The ongoing Phase 3 FLASH2 study builds upon previous clinical evidence and aims to provide the confirmatory data needed for regulatory submissions.

Successful completion of this second Phase 3 study would support regulatory approvals for commercialization worldwide, addressing a significant unmet medical need in the cutaneous T-cell lymphoma treatment landscape. The disease affects approximately 20,000 to 30,000 patients in the United States alone, with current treatment options often providing limited efficacy or causing substantial side effects. The promising response rate observed to date suggests HyBryte could become an important new therapeutic option for this patient population. Additional information about Soligenix and its development programs can be found at https://ibn.fm/SNGX.

The interim analysis planned for 2026 will provide critical insights into the therapy's efficacy and safety profile, potentially accelerating the path to regulatory approval and patient access. The study's design allows for potential early success recognition based on the interim results, which could streamline the regulatory review process. With cutaneous T-cell lymphoma patients often cycling through multiple treatments with diminishing returns, the development of new effective therapies like HyBryte represents an important advancement in oncology care for rare diseases.