Soligenix Inc. is developing HyBryte, a novel photodynamic therapy for early-stage cutaneous T-cell lymphoma that uses visible light activation to target malignant cells while minimizing damage to healthy tissue. Cutaneous T-cell lymphoma presents significant diagnostic challenges in its early stages, creating a difficult treatment landscape that Soligenix aims to address through this innovative approach.
HyBryte, also known as synthetic hypericin, represents a departure from traditional ultraviolet-based phototherapies that carry long-term safety risks with cumulative exposure. The therapy is activated by visible light in the red-yellow spectrum, allowing for targeted treatment of malignant T-cells in the skin. Clinical data reported by Soligenix indicate that HyBryte has demonstrated statistically significant efficacy in reducing CTCL lesions in patients with early-stage disease.
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. Additional information about the company's development programs can be found at https://www.Soligenix.com.
Beyond HyBryte, Soligenix's development programs include expansion of synthetic hypericin into psoriasis treatment, first-in-class innate defense regulator technology for inflammatory diseases, and vaccine programs targeting various public health threats. The company's Public Health Solutions business segment has been supported with government grants and contract funding from agencies including the National Institute of Allergy and Infectious Diseases, the Defense Threat Reduction Agency, and the Biomedical Advanced Research and Development Authority.
The development of HyBryte addresses a critical unmet medical need in the treatment of rare diseases, particularly for patients with early-stage CTCL who require effective therapies with improved safety profiles. As Soligenix moves toward potential commercialization of this visible light-activated photodynamic therapy, the treatment could offer clinicians a more targeted approach to managing this difficult-to-diagnose cancer while reducing long-term safety concerns associated with traditional phototherapies.
