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Clinical Trials

Soligenix has specialized clinical trial 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.

Topical SGX302 for Mild-to-Moderate Psoriasis

Soligenix will begin recruiting patients into this Phase 2 study with sites in the US.

Phase 2a Study Evaluating SGX302 in the Treatment of Mild-to-Moderate Psoriasis

This study is to evaluate SGX302 (topical synthetic hypericin ointment) with visible light in an initial 18-week treatment course for improving lesions in patients with mild-to-moderate psoriasis. Patient enrollment is expected to begin in the fourth quarter of 2022.

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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: The primary endpoint of median duration of SOM did not achieve the pre-specified criterion for statistical significance (p≤0.05); although biological activity was observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group.  Despite this clinically meaningful improvement, the variability in the distribution of the data yielded a p-value that was not statistically significant. Other secondary endpoints supported the biological activity of dusquetide, including a statistically significant 50% reduction in the duration of SOM in the per-protocol population, which decreased from 18 days in the placebo group to 9 days in the SGX942 treatment group (p=0.049), consistent with the findings in the Phase 2 trial.  Similarly, incidence of SOM also followed this biological trend as seen in the Phase 2 study, decreasing by 16% in the SGX942 treatment group relative to the placebo group in the per-protocol population. 

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FLASH Clinical Study: Fluorescent Light Activated Synthetic Hypericin

Soligenix has completed this Phase 3 study and the final results have been published in Journal of the American Medical Association (JAMA) Dermatology.

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: HyBryte™ treatment statistically significantly reduced lesion size, with the treatment response further improving over successive 6-week treatment cycles. The primary endpoint evaluated the CAILS (Composite Assessment of Index Lesion Severity) score of three treated index lesions and success was defined as ≥50% reduction in CAILS score relative to baseline. Lesion response continuously improved with treatment duration. After the first 6-week treatment window, 16% of patients had a response (p=0.04 versus patients with 6 weeks of placebo treatment; primary endpoint). This response rate continued to significantly increase to 49% through 18 weeks of treatment (p<0.0001 versus patients with 6-week hypericin or placebo treatment). Throughout the study, HyBryte™ was safe and well-tolerated. Importantly, HyBryte™ was observed to perform similarly against both patch and thicker plaque lesions characteristic of CTCL. More detail regarding the results of the Phase 3 FLASH study can be found in the published article in JAMA Dermatology.  

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