EQS-News: Soligenix's HyBryte(TM) Shows 75% Response Rate In Skin Cancer Trial, Backed By FDA Funding

By Johnny Rice Benzinga

DETROIT, MICHIGAN - April 24, 2025 (NEWMEDIAWIRE) - Soligenix (NASDAQ: SNGX) recently announced an exciting update for its novel skin cancer treatment. The company reports that its flagship product candidate, HyBryte™, is showing impressive results in treating a rare form of skin cancer called cutaneous T-cell lymphoma or CTCL, with 75% of patients seeing significant improvement after just 18 weeks.

The treatment appears to be working well in real-world testing. Of the eight patients evaluated so far, six showed major improvement in their skin lesions. Even more impressive, Soligenix reports that three patients achieved a complete response - meaning their lesions essentially disappeared. For patients who completed the full 54-week treatment, the average improvement was a substantial 85%.

Watch here: Soligenix $SNGX HyBryte™ Shows 75% Response Rate In Skin Cancer Trial, Backed By FDA Funding

Unlike many current treatments that can take 6-12 months to work and often have serious side effects, HyBryte™ so far appears to work faster - showing results at 18 weeks - and appears much safer. It uses visible light rather than harmful UV radiation, significantly reducing the risk of causing new cancers, which is a common problem with existing treatments.

Dr. Ellen Kim of the University of Pennsylvania, who's leading the study, expressed excitement about the consistent results and safety profile across multiple clinical trials. The FDA recognizes the potential here, too – they're funding this study with a $2.6 million grant through their Orphan Products Development program.

For investors, several potential catalysts to watch for are lining up:

• The company is now enrolling patients in its confirmatory Phase 3 FLASH2 trial

• Results continue supporting HyBryte as potentially the first safe, front-line treatment for this disease

• The therapy could expand into home use, making it more convenient for patients

The market opportunity is significant enough for the company, despite CTCL being rare. 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.

With approximately 38,000 patients also suffering in Europe, and very few effective treatment options available, HyBryte could capture substantial market share if approved.

SNGX represents a late-stage company with promising clinical data, government funding support and a focused path toward potentially bringing a safer, more effective treatment to market for an underserved patient population.

Featured image by Free-Photos on Unsplash.

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