Soligenix Inc ((SNGX)) announced an update on their ongoing clinical study.
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Study Overview: Soligenix Inc. is conducting a Phase 3 clinical 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 patch/plaque phase CTCL, a type of skin lymphoma. This study is significant as it seeks to provide a new treatment option for a condition with limited therapies.
Intervention/Treatment: The study tests HyBryte, a gel containing 0.25% hypericin, applied twice weekly for 18 weeks. The treatment involves covering lesions with opaque material and exposing them to visible light 21 hours later. The placebo group receives a similar gel without the active ingredient.
Study Design: This interventional study uses a randomized, parallel assignment model with quadruple masking (participant, care provider, investigator, outcomes assessor) to ensure unbiased results. Its primary purpose is to assess the treatment’s efficacy.
Study Timeline: The study began on January 7, 2025, with primary completion expected in the coming months. The latest update was submitted on July 28, 2025. These dates are crucial for tracking the study’s progress and anticipating results.
Market Implications: The progress of this study could impact Soligenix’s stock performance, as successful results may enhance investor confidence and market position. The treatment’s potential approval could also influence the competitive landscape in the CTCL treatment market, where few effective options exist.
The study is currently recruiting, with further details available on the ClinicalTrials portal.