Curated News
By: NewsRamp Editorial Staff
November 19, 2025
Soligenix Hits Key Milestone in CTCL Treatment Trial with 48% Response Rate
TLDR
- Soligenix's HyBryte shows 48% response rate in CTCL trial, exceeding expectations and positioning it as a potential market leader in rare disease treatment.
- Soligenix completed enrollment for its Phase 3 FLASH2 study of HyBryte in cutaneous T-cell lymphoma, with interim analysis planned for Q2 2026 and topline data expected in H2 2026.
- HyBryte's promising efficacy in treating cutaneous T-cell lymphoma offers hope for patients with rare diseases who currently have limited treatment options available.
- Soligenix's novel photodynamic therapy uses safe visible light to treat cancer, achieving nearly double the expected response rate in ongoing clinical trials.
Impact - Why it Matters
This development represents a significant advancement for patients suffering from cutaneous T-cell lymphoma, a rare and often difficult-to-treat form of skin cancer. The 48% response rate substantially exceeds expectations and suggests HyBryte could become an important new treatment option for a condition with limited therapeutic choices. For the broader pharmaceutical landscape, Soligenix's progress demonstrates the viability of photodynamic therapies for cancer treatment and highlights the importance of continued investment in rare disease research. The successful enrollment milestone also positions the company closer to potential regulatory approval and commercialization, which could provide new hope for CTCL patients worldwide while validating Soligenix's specialized approach to addressing unmet medical needs in rare diseases.
Summary
Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company developing treatments for rare diseases with unmet medical need, has achieved a significant milestone by completing enrollment of the 50 patients required for the interim analysis in its 80-patient confirmatory Phase 3 FLASH2 study. The study evaluates HyBryte™, the company's novel photodynamic therapy for cutaneous T-cell lymphoma (CTCL), a rare form of skin cancer. The interim analysis is scheduled for the second quarter of 2026, with topline data expected in the second half of that year. Most notably, the company reported an overall blinded response rate of 48 percent among patients who have completed treatment to date, substantially exceeding the anticipated 25 percent rate used in the study's powering assumptions. Investigators have also reported safety findings consistent with earlier studies, with HyBryte continuing to demonstrate encouraging efficacy signals across the ongoing development program.
Soligenix's Specialized BioTherapeutics business segment is focused on developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy that utilizes safe visible light for treating CTCL. With successful completion of this second Phase 3 study, the company plans to seek regulatory approvals to support potential commercialization worldwide. The company's development pipeline also includes expanding synthetic hypericin (SGX302) into psoriasis treatment, their first-in-class innate defense regulator technology dusquetide (SGX942) for inflammatory diseases including oral mucositis in head and neck cancer, and SGX945 for Behcet's Disease. The company's Public Health Solutions business segment includes development programs for RiVax®, their ricin toxin vaccine candidate, as well as vaccine programs targeting filoviruses and CiVax™ for COVID-19 prevention, incorporating their proprietary heat stabilization platform technology ThermoVax®.
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Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, Soligenix Hits Key Milestone in CTCL Treatment Trial with 48% Response Rate
