Soligenix Inc ((SNGX)) announced an update on their ongoing clinical study.
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Soligenix Inc. is conducting a Phase 3 study titled ‘A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte™ (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)’. The study aims to evaluate the effectiveness of HyBryte, a topical photosensitizing agent, in treating patients with cutaneous T-cell lymphoma, specifically in its patch/plaque phase.
The intervention being tested is HyBryte, a gel containing 0.25% hypericin, applied twice weekly for 18 weeks. It is designed to be activated by visible light to treat CTCL. A placebo gel is used as a comparator in the study.
This interventional study is randomized with a parallel assignment model. It employs a quadruple masking approach, meaning the participant, care provider, investigator, and outcomes assessor are all blinded to the treatment allocation. The primary purpose of the study is treatment.
The study began on June 17, 2024, with the primary completion and estimated completion dates yet to be announced. The most recent update was submitted on July 28, 2025, indicating ongoing recruitment.
The outcome of this study could significantly impact Soligenix’s market position, particularly if HyBryte proves effective. Positive results may boost investor confidence and elevate stock performance, especially in the competitive oncology treatment market.
The study is ongoing, and further details are available on the ClinicalTrials portal.