Soligenix Inc. (NASDAQ: SNGX) is building momentum in the treatment of early-stage cutaneous T-cell lymphoma (CTCL) through promising results from its pivotal FLASH trial and ongoing FLASH 2 confirmatory study. HyBryte—a novel, non-UV light-activated therapy using synthetic hypericin—has demonstrated statistically significant efficacy and safety, offering hope in a field where therapeutic innovation has lagged.
In the original FLASH study, nearly half of patients showed meaningful response at 18 weeks. Interim results from an independent University of Pennsylvania study reported a 75% response rate. FLASH 2 builds on these findings with improved design while addressing regulatory requirements for confirmatory evidence. If successful, HyBryte could become the first approved front-line therapy for early-stage CTCL, reshaping standards of care and strengthening Soligenix’s position as a leader in rare dermatologic oncology.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing HyBryte as a novel photodynamic therapy utilizing safe visible light for the treatment of CTCL. With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide.
Development programs also include expansion of synthetic hypericin into psoriasis, the company’s first-in-class innate defense regulator technology, dusquetide for the treatment of inflammatory diseases including oral mucositis in head and neck cancer, and SGX945 in Behçet’s disease. The company’s Public Health Solutions business segment includes development programs for RiVax, its ricin toxin vaccine candidate, as well as vaccine programs targeting filoviruses and CiVax, the company’s vaccine candidate for the prevention of COVID-19.
The development of Soligenix’s vaccine programs incorporates its proprietary heat stabilization platform technology, ThermoVax. To date, this business segment has been supported with government grants and contract funding from the National Institute of Allergy and Infectious Diseases, the Defense Threat Reduction Agency, and the Biomedical Advanced Research and Development Authority. For further information, visit the company’s website at www.Soligenix.com.
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