Curated News
By: NewsRamp Editorial Staff
September 30, 2025
Soligenix Expands European Board for HyBryte™ CTCL Trial
TLDR
- Soligenix's European Medical Advisory Board expansion positions the company for competitive advantage in CTCL treatment market ahead of potential 2026 commercialization.
- Soligenix is conducting an 18-week Phase 3 trial enrolling 80 patients to confirm HyBryte's efficacy in early-stage cutaneous T-cell lymphoma.
- This advancement brings hope for better treatment options for rare disease patients, potentially improving quality of life for those with CTCL.
- Soligenix's novel photodynamic therapy uses safe visible light to treat cutaneous T-cell lymphoma, representing innovative medical technology development.
Impact - Why it Matters
This development matters because cutaneous T-cell lymphoma is a rare and often debilitating cancer with limited treatment options, particularly for early-stage patients. The advancement of HyBryte™ represents a potential breakthrough in photodynamic therapy that could offer a safer, more targeted approach compared to existing treatments. For patients suffering from this condition, successful development could mean improved quality of life and better disease management. From a broader perspective, Soligenix's progress demonstrates the ongoing innovation in rare disease therapeutics and highlights the importance of specialized biopharmaceutical companies addressing unmet medical needs that larger pharmaceutical firms often overlook. The European expansion also signals growing international recognition of this treatment approach, potentially accelerating global access if regulatory approvals are secured.
Summary
Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company, has announced a significant expansion of its European Medical Advisory Board to guide the confirmatory Phase 3 trial of HyBryte™ in early-stage cutaneous T-cell lymphoma. This strategic move strengthens European engagement ahead of potential commercialization and demonstrates the company's commitment to advancing this novel treatment. The 18-week study is expected to enroll approximately 80 patients, with top-line results anticipated in the second half of 2026, marking a crucial milestone in the development pathway for this rare disease therapy.
Soligenix's Specialized BioTherapeutics business segment is focused on developing HyBryte™ (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy that utilizes safe visible light for treating cutaneous T-cell lymphoma. The company's broader development pipeline includes expanding synthetic hypericin into psoriasis treatment, developing first-in-class innate defense regulator technology with dusquetide for inflammatory diseases including oral mucositis in head and neck cancer, and advancing treatments for Behçet's Disease. The company's comprehensive approach to rare disease treatment extends beyond oncology through its Dynamic Brand Portfolio of therapeutic solutions.
The company's Public Health Solutions business segment features additional promising candidates including RiVax® ricin toxin vaccine and vaccine programs targeting filoviruses such as Marburg and Ebola, along with CiVax™ for COVID-19 prevention. These programs leverage Soligenix's proprietary ThermoVax® heat stabilization platform technology and have received substantial government support from agencies including the National Institute of Allergy and Infectious Diseases, the Defense Threat Reduction Agency, and the Biomedical Advanced Research and Development Authority. For investors seeking the latest updates, comprehensive information about SNGX is available through the InvestorBrandNetwork platform, which provides specialized communications and advanced wire-grade press release syndication services to effectively reach target markets and diverse industries.
Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, Soligenix Expands European Board for HyBryte™ CTCL Trial
