Soligenix Inc. has expanded its European Medical Advisory Board to guide the confirmatory Phase 3 trial of HyBryte in early-stage cutaneous T-cell lymphoma. The 18-week study is enrolling approximately 80 patients, with top-line results expected in the second half of 2026. This expansion represents a strategic move to strengthen European engagement ahead of potential commercialization of the novel photodynamic therapy.
The company's Specialized BioTherapeutics business segment is developing HyBryte as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. This development is significant because cutaneous T-cell lymphoma represents a rare disease with limited treatment options, particularly those utilizing visible light technology that offers potential safety advantages over conventional therapies.
Beyond the HyBryte program, Soligenix's development pipeline includes expansion of synthetic hypericin into psoriasis treatment, representing potential broader applications for the technology. The company is also advancing its first-in-class innate defense regulator technology, dusquetide, for the treatment of inflammatory diseases including oral mucositis in head and neck cancer patients. Additional development includes SGX945 for Behcet's Disease, demonstrating the company's commitment to addressing multiple rare disease indications.
The company maintains a separate Public Health Solutions business segment that includes development programs for RiVax, a ricin toxin vaccine candidate, as well as vaccine programs targeting filoviruses such as Marburg and Ebola. This segment also includes CiVax, a vaccine candidate for the prevention of COVID-19 caused by SARS-CoV-2. These public health initiatives incorporate the company's proprietary heat stabilization platform technology known as ThermoVax, which has received government grant and contract funding from multiple agencies including the National Institute of Allergy and Infectious Diseases, the Defense Threat Reduction Agency, and the Biomedical Advanced Research and Development Authority.
The expansion of the European Medical Advisory Board comes at a critical juncture as Soligenix prepares for potential global commercialization of HyBryte. The company's newsroom provides additional updates and information about these developments. For investors and stakeholders following the company's progress, the latest news and updates relating to SNGX are available through the company's communications channels. The full press release detailing this advisory board expansion and study progress can be accessed for comprehensive information about these clinical developments.
