Cutaneous T-cell lymphoma presents significant diagnostic challenges in early stages, creating treatment gaps that Soligenix Inc. aims to address through its development of HyBryte™. The novel therapeutic approach utilizes synthetic hypericin activated by visible light in the red-yellow spectrum, representing a departure from traditional ultraviolet-based phototherapies that carry long-term safety risks with cumulative exposure.
Clinical data reported by Soligenix indicates HyBryte has demonstrated statistically significant efficacy in reducing CTCL lesions in patients with early-stage disease. The visible light activation allows targeted treatment of malignant T-cells in the skin while minimizing damage to surrounding healthy tissue, potentially offering a safer alternative for patients requiring ongoing therapy.
Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs. The company's Specialized BioTherapeutics business segment is advancing HyBryte toward potential commercialization following successful completion of a second Phase 3 study. Regulatory approvals will be sought to support worldwide commercialization of the therapy.
The development of HyBryte addresses critical treatment gaps in CTCL management, particularly for early-stage disease where accurate diagnosis remains challenging for clinicians. The therapy's mechanism represents an innovation in photodynamic treatment approaches, potentially establishing new standards for safety and efficacy in this difficult-to-treat cancer.
Beyond CTCL, Soligenix is expanding synthetic hypericin development into psoriasis treatment and advancing other therapeutic candidates including dusquetide for inflammatory diseases. The company maintains a Public Health Solutions business segment developing vaccine candidates for ricin toxin, filoviruses, and COVID-19, supported by government grants and contracts from agencies including the National Institute of Allergy and Infectious Diseases.
For additional information about Soligenix's development programs, visit https://www.Soligenix.com. The company's progress in addressing rare disease treatment gaps through innovative approaches like HyBryte represents significant advancement in oncology therapeutics, particularly for conditions with limited treatment options and challenging diagnostic pathways.
