Curated News
By: NewsRamp Editorial Staff
November 19, 2025
Soligenix Hits Key Milestone in Cutaneous T-Cell Lymphoma Treatment Trial
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 interim analysis, with data expected in 2026 following a blinded 48% response rate in CTCL patients.
- HyBryte's promising results offer new hope for cutaneous T-cell lymphoma patients, potentially improving quality of life for those with rare diseases.
- Soligenix's novel photodynamic therapy uses safe visible light to treat CTCL, showing nearly double the expected response rate in ongoing trials.
Impact - Why it Matters
This development represents a significant advancement for patients suffering from cutaneous T-cell lymphoma, a rare and often debilitating cancer that currently lacks optimal treatment options. The impressive 48% response rate far exceeds expectations and suggests HyBryte could become a valuable new therapeutic option for this underserved patient population. For the broader pharmaceutical landscape, Soligenix's success demonstrates the viability of photodynamic therapy approaches and highlights the importance of continued investment in rare disease treatments. The company's progress also validates their specialized focus on addressing unmet medical needs, potentially paving the way for additional innovations in their pipeline targeting other inflammatory conditions and infectious 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 (TM) in cutaneous T-cell lymphoma, with the interim analysis scheduled for the second quarter of 2026 and topline data expected in the second half of the year. The company reported an impressive 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 noted 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 advancing HyBryte (TM) (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for treating cutaneous T-cell lymphoma. The company's broader development pipeline includes expanding synthetic hypericin (SGX302) into psoriasis treatment, developing first-in-class innate defense regulator technology with 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, supported by government funding from agencies including NIAID, DTRA and BARDA, focuses on vaccine development including RiVax(R) for ricin toxin, filovirus vaccines targeting Marburg and Ebola, and CiVax(TM) for COVID-19 prevention, all incorporating the proprietary ThermoVax(R) heat stabilization platform technology.
This news was distributed through the InvestorBrandNetwork's Dynamic Brand Portfolio, which includes InvestorWire as a specialized communications platform providing advanced wire-grade press release syndication and comprehensive corporate communications solutions. The platform offers broad distribution capabilities including article and editorial syndication to over 5,000 outlets, enhanced press release services, social media distribution to millions of followers, and tailored corporate communications solutions designed to help companies reach wide audiences of investors, influencers, consumers, and journalists while cutting through market information overload.
Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, Soligenix Hits Key Milestone in Cutaneous T-Cell Lymphoma Treatment Trial
