Cutaneous T-Cell Lymphoma (CTCL) is a rare type of Non-Hodgkin’s Lymphoma affecting T-cells, with Mycosis Fungoides being its most prevalent form. Early-stage CTCL is characterized by skin lesions and plaques, while more severe forms, like Sézary Syndrome, have a lower survival rate. Treatment focuses on symptomatic relief and slowing disease progression, often requiring lifelong management to minimize side effects.
HyBryte™ (SGX301 or synthetic hypericin) represents a breakthrough in CTCL treatment. This ointment, containing the photosensitive compound hypericin, is applied to CTCL lesions and activated by visible light, leading to the death of malignant T-cells. Unlike other photodynamic therapies that use ultraviolet light, HyBryte™'s use of visible light allows for deeper skin penetration without significant carcinogenic risk.
The Phase 3 FLASH study, the largest of its kind, enrolled 169 patients with early-stage CTCL. Participants underwent three 8-week treatment cycles, with significant improvements observed in lesion severity. The study found a 16% response rate in the first cycle, increasing to 40% and 49% after two and three cycles, respectively. Both patch and plaque lesions responded well to treatment, with response rates of 37% and 42% after two cycles.
Safety results were equally promising, with only 2.4% of adverse events (AEs) being serious and 4% severe. Most AEs were mild to moderate skin-related events, such as pruritus and erythema, occurring in 16% of HyBryte™ treated patients versus 10% of placebo patients. The therapy demonstrated fewer safety concerns compared to other second-line treatments, with a low dropout rate of 5%.
HyBryte™'s unique attributes include its use of synthetic hypericin, activation by safe visible light, and the absence of direct DNA damage. Its rapid treatment response, effectiveness against both patches and plaques, and potential for home-use device development position it as a significant advancement in early-stage CTCL treatment. Despite its promising results, HyBryte™ is not yet approved for sale in any jurisdiction.
