By Kyle Anthony, Benzinga

Mycosis fungoides is a type of skin cancer that affects the body’s T cells, which are white blood cells intended to protect the body from infection. It is the most common form of cutaneous T-cell lymphoma (CTCL), the category name given to a diverse and complex group of rare skin cancers.

As reported by the Cutaneous Lymphoma Foundation, approximately 3,000 new CTCL cases are reported in the U.S. every year, with as many as 20,000-30,000 living with this chronic, incurable disease. CTCL is more common in men than women and in patients older than 50 compared to younger people. By 70 years old, there is a four-fold increase in CTCL cases.

Soligenix Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases and areas of unmet medical need, reports that it is on the cusp of treating CTCL with its lead product candidate, HyBryte™.

HyBryte is a photodynamic therapy that uses synthetically manufactured hypericin in an ointment or gel combined with safe, visible fluorescent or LED light. When exposed to certain types of light, hypericin produces energy capable of destroying nearby cells, particularly harmful and diseased ones.

This light therapy treatment has two parts. First, the drug (synthetic hypericin) is applied topically to the skin. Then, it is activated by visible light. Soligenix reports that synthetic hypericin, the active ingredient in HyBryte, tends to accumulate in T cells. Once the hypericin is in the T-cells, it can be activated by safe, visible light. When synthetic hypericin is activated, it creates oxygen radicals, which subsequently cause cellular toxicity, killing the targeted T-cells.

Clinical phase 1, 2 and 3 studies conducted by Soligenix have demonstrated HyBryte treatment efficacy, including for treating surface patches on the skin and thicker plaques that are typically more resistant to treatment. The phase 3 study evaluated the efficacy and safety of HyBryte in patients with different stages of mycosis fungoides. The results indicated a significant improvement in patients who took HyBryte, particularly those with longer treatment durations.

In speaking about the clinical study’s findings, Dr. Richard Straube, MD, senior vice president and chief medical officer of Soligenix, stated, “In treating CTCL, which is a chronic cancer with no cure, long-term safety is of paramount concern. Most current treatment options for CTCL are associated with significant safety concerns, including black-box warnings. HyBryte™ treatment has demonstrated strong and rapid efficacy with a very benign safety profile. This is of significant benefit to patients living with this difficult disease. The substantial increase in efficacy with longer treatment and the similar performance against both patch and plaque lesions are particularly encouraging. As one of the largest studies in CTCL, this study and this publication establishes a new benchmark in CTCL treatment.”

Following the success of the phase 3 study, Soligenix is initiating a second confirmatory phase 3 trial in 80 CTCL patients. The objective of this study is to support potential marketing approval worldwide. The study is set to open for enrollment before year-end and will have topline results in 2026. Soligenix Inc.’s CEO and President, Christopher Schaber, PhD, is committing to providing enrollment updates as they become available.

The study is expected to enroll more quickly than the first, as patients from the first trial have the potential to be included in the second. The company is also working with many of the key opinion leaders and patient advocacy groups in the CTCL space.

Soligenix's focus on developing and commercializing products to treat rare diseases in areas of unmet medical need is aimed at developing a distinct value proposition within the marketplace that is not easily replicable over time. The progress of HyBryte so far is indicative of the firm’s commitment to innovative, scientific development and meaningfully impacting the lives of individuals across the globe.

Featured photo by National Cancer Institute on Unsplash.

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