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 in developing a novel treatment for a rare disease with 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 HyBryte may demonstrate stronger efficacy than initially projected, potentially offering new hope for patients with cutaneous T-cell lymphoma who have few effective treatment alternatives. Investigators have reported 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 successful completion of this second Phase 3 study could lead to regulatory approvals supporting potential commercialization worldwide. The treatment's development is particularly important given the unmet medical needs in rare diseases like cutaneous T-cell lymphoma, where patients often face limited treatment options and poor outcomes.
The interim analysis completion marks a critical step toward potential regulatory approval and commercialization of HyBryte. For patients suffering from cutaneous T-cell lymphoma, this development could mean access to a new, potentially more effective treatment option with a favorable safety profile. The biopharmaceutical industry will be watching closely as this therapy progresses through the regulatory pathway, as successful development could establish new standards for treating this challenging condition. Additional information about the company's developments is available in their newsroom at https://ibn.fm/SNGX.
Beyond the FLASH2 study, Soligenix's development programs include expanding synthetic hypericin into psoriasis treatment and developing first-in-class innate defense regulator technology for inflammatory diseases. The company's Public Health Solutions business segment includes vaccine programs targeting various infectious diseases, supported by government funding from agencies including the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority. The progress in the HyBryte development program represents an important advancement in addressing significant unmet medical needs in rare disease treatment.
