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Clinical Trials

Soligenix has specialized expertise

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need.

Soligenix has specialized expertise in the development of orphan and unmet medical need indications – including the regulatory nuances (Orphan Drug designation, Fast Track designation, use of adaptive trial designs etc.) and clinical execution (specialized recruitment approaches, direct site interactions etc.). Soligenix directly conducts all of its Phase 2 and 3 clinical studies, being in personal contact with the sites and principal investigators, ensuring the highest data quality while streamlining timelines and budgets.

DOM-Innate Study: Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity

Soligenix has completed recruiting patients into this Phase 3 study with sites in the US and Europe.

A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study of SGX942 for the Treatment of Oral Mucositis in Patients Being Treated with Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to evaluate the safety and efficacy of SGX942 in reducing the duration of severe oral mucositis associated with chemoradiation therapy in patients receiving these treatments for the treatment of head and neck cancer. Approximately 260 subjects were enrolled in the study. Topline results are expected in 4Q 2020.

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FLASH Study: Fluorescent Light Activated Synthetic Hypericin

Soligenix has completed recruiting patients into this Phase 3 study with sites in the US.

A Pivotal Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Determine the Efficacy of Topical HyBryte™ (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL).

The purpose of this study is to evaluate the use of HyBryte™, a novel topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides). We enrolled approximately 160 subjects in total.

Topline results indicate that 40% of patients responding to HyBryte™ treatment after only 12 weeks of treatment (p<0.0001). No concerning safety signals were noted. Follow-up visits are ongoing and expected to be complete in 4Q 2020.

Learn more about HyBryte™ trial on