Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company, is advancing its phase 3 replication study (“FLASH2”) for HyBryte(TM), a novel photodynamic therapy designed to treat early-stage cutaneous T-cell lymphoma (“CTCL”). Building on the success of a prior phase 3 trial, HyBryte(TM)—which uses synthetic hypericin activated by safe visible light—offers a potentially game-changing approach by providing a noninvasive, well-tolerated alternative that targets malignant T-cells with precision. With patient enrollment underway and interim analysis expected in early 2026, the study is designed to potentially meet the stringent requirements of regulatory agencies in order to strengthen the case for HyBryte(TM) as a commercially available treatment. This milestone emphasizes Soligenix’s broader strategy of using innovative therapeutic approaches to tackle rare and difficult-to-treat diseases. The progress of HyBryte(TM) also underscores the importance of photodynamic therapy as a new and effective modality that could potentially be applied to other dermatological and oncological conditions.
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About Soligenix Inc.
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 and moving toward potential commercialization of HyBryte(TM) (“SGX301” or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (“SGX302”) into psoriasis, the company’s first-in-class innate defense regulator (“IDR”) technology, dusquetide (“SGX942”) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (“SGX945”) in Behçet’s disease.
Soligenix’s Public Health Solutions business segment includes development programs for RiVax(R), its ricin toxin vaccine candidate, as well as its vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax(TM), its vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of its vaccine programs incorporates the use of the company’s proprietary heat stabilization platform technology, known as ThermoVax(R). To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Defense Threat Reduction Agency (“DTRA”) and the Biomedical Advanced Research and Development Authority (“BARDA”).
For further information regarding Soligenix, visit the company’s website at www.Soligenix.com.
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