Soligenix Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company, is making substantial headway in the treatment of cutaneous T-cell lymphoma (CTCL), a rare and complex group of skin cancers. The company’s lead product candidate, HyBryte™, is showing promising results in clinical trials for treating mycosis fungoides, the most common form of CTCL.
CTCL affects approximately 3,000 new patients in the United States annually, with an estimated 20,000 to 30,000 individuals living with this chronic, incurable disease. The condition disproportionately affects men and individuals over 50, with a significant increase in cases among those 70 and older.
HyBryte utilizes a novel photodynamic therapy approach, combining synthetically manufactured hypericin in an ointment or gel form with safe, visible fluorescent or LED light. This two-step treatment involves topical application of the drug followed by light activation. The synthetic hypericin accumulates in T cells and, when activated by light, creates oxygen radicals that cause cellular toxicity, effectively targeting and destroying cancerous T-cells.
The efficacy of HyBryte has been demonstrated through phase 1, 2, and 3 clinical studies conducted by Soligenix. These trials have shown positive results in treating both surface patches on the skin and thicker plaques that are typically more resistant to treatment. The phase 3 study published in JAMA Dermatology revealed significant improvements in patients treated with HyBryte, particularly those undergoing longer treatment durations.
Dr. Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix, emphasized the importance of HyBryte’s safety profile in treating CTCL. Unlike many current treatment options that come with significant safety concerns and black-box warnings, HyBryte has demonstrated strong and rapid efficacy with a benign safety profile. This characteristic is particularly beneficial for patients living with this challenging disease.
Building on the success of its initial phase 3 study, Soligenix is initiating a second confirmatory phase 3 trial involving 80 CTCL patients. This study aims to support potential marketing approval worldwide and is scheduled to begin enrollment before the end of the year, with topline results expected in 2026. Christopher Schaber, PhD, CEO and President of Soligenix Inc., has committed to providing regular enrollment updates as they become available.
The company anticipates faster enrollment for this second trial, as patients from the first study may be eligible to participate. Soligenix is also collaborating with key opinion leaders and patient advocacy groups in the CTCL space to facilitate the study’s progress.
Soligenix’s focus on developing treatments for rare diseases in areas of unmet medical need positions the company to create a unique value proposition in the marketplace. The progress of HyBryte demonstrates the firm’s commitment to innovative scientific development and its potential to significantly impact the lives of individuals affected by CTCL globally.
As Soligenix advances its research and development efforts, the company’s work in treating CTCL with HyBryte represents a significant step forward in addressing a challenging and underserved area of oncology. The potential approval and commercialization of HyBryte could offer new hope to patients struggling with this rare and difficult-to-treat form of skin cancer.
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