Soligenix Advances HyBryte as Potential First-Line CTCL Treatment with Promising Clinical Results

Soligenix Inc. continues to demonstrate progress in treating early-stage cutaneous T-cell lymphoma through promising results from its pivotal FLASH trial and ongoing FLASH 2 confirmatory study. The company's HyBryte therapy represents a novel approach using synthetic hypericin activated by non-UV light, showing statistically significant efficacy and safety profiles in clinical testing. This development is particularly significant in a therapeutic area where innovation has historically been limited, offering new hope for patients with this rare form of lymphoma.

The original FLASH study demonstrated that nearly half of patients achieved meaningful response at 18 weeks of treatment, while interim results from an independent University of Pennsylvania study reported an even more impressive 75% response rate. These findings suggest HyBryte could substantially improve treatment outcomes for early-stage CTCL patients who currently lack standardized front-line therapies. The FLASH 2 confirmatory study builds upon these initial results with an improved design while addressing regulatory requirements for additional evidence.

If successful in ongoing clinical development and regulatory review, HyBryte could become the first approved front-line therapy for early-stage CTCL, potentially reshaping standards of care in dermatologic oncology. This advancement would represent a significant milestone for both patients and healthcare providers, offering a targeted treatment option with demonstrated safety and efficacy. The therapy's non-UV light activation mechanism distinguishes it from existing treatments, potentially reducing long-term side effects associated with conventional phototherapy approaches.

Beyond its CTCL program, Soligenix maintains additional development pipelines through its Specialized BioTherapeutics and Public Health Solutions business segments. The company's broader research includes expanding synthetic hypericin applications into psoriasis treatment and developing first-in-class innate defense regulator technology for inflammatory diseases. Additional information about the company's research and development programs can be found at https://www.Soligenix.com. The ongoing progress in CTCL treatment reflects Soligenix's strategic focus on addressing unmet medical needs in rare diseases through innovative therapeutic approaches.