Soligenix (NASDAQ:SNGX) announced the peer-reviewed publication of clinical data today, reinforcing the potential of its lead candidate, HyBryte™, to provide a safer and more effective alternative to the current standard of care for early-stage cutaneous T-cell lymphoma (CTCL).
The study, published in the medical journal Oncology and Therapy, compared HyBryte (synthetic hypericin) directly against Valchlor® (mechlorethamine), one of the most widely prescribed topical treatments for the rare blood cancer.
Over a 12-week treatment period, 60% of patients treated with HyBryte achieved "Treatment Success"—defined as at least a 50% improvement in lesion scores—compared to just 20% of patients in the Valchlor group.
While the study’s small sample size meant the results did not reach statistical significance, the clinical trends were stark.
The average cumulative improvement in the mCAILS score (a standard measure of lesion severity) was 52.5% for HyBryte patients versus 34.7% for those using Valchlor.
Notably, HyBryte achieved these results despite the randomized group containing patients with more extensive baseline disease.
The safety data provided a significant point of differentiation.
In the trial, 60% of Valchlor users experienced therapy-related adverse events, including rashes and allergic contact dermatitis, with one patient forced to permanently discontinue treatment.
In contrast, 100% of the HyBryte patients tolerated the therapy well, with zero reported adverse events related to the medication.
The publication comes as Soligenix continues to advance HyBryte toward potential commercialization.