Soligenix Expands European Medical Advisory Board to Advance HyBryte Phase 3 Study for Cutaneous T-Cell Lymphoma

Soligenix Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on treatments for rare diseases, has announced the expansion of its European Medical Advisory Board to guide its 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, as the company strengthens European engagement ahead of potential commercialization.

This expansion represents a strategic move to enhance the company's European presence and expertise for the HyBryte clinical development program. The European Medical Advisory Board will provide critical guidance for the Phase 3 trial design, implementation, and interpretation of results, potentially accelerating the path to regulatory approval and market access across European countries. The timing of this expansion suggests Soligenix is preparing for a coordinated global regulatory strategy, recognizing the importance of European markets for orphan drug commercialization.

HyBryte represents a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, a rare form of non-Hodgkin lymphoma that affects the skin. The treatment, also known as SGX301 or synthetic hypericin sodium, offers a potentially safer alternative to existing therapies that often involve ultraviolet light, which carries known carcinogenic risks. The successful completion of this second Phase 3 study could lead to regulatory approvals supporting commercialization worldwide, addressing a significant unmet medical need in the rare disease space.

The implications of this development extend beyond the immediate clinical trial. For patients suffering from cutaneous T-cell lymphoma, HyBryte could provide a new treatment option with a more favorable safety profile. The expansion of the European Medical Advisory Board indicates Soligenix's commitment to building relationships with key opinion leaders and regulatory experts in Europe, which could facilitate smoother market entry if the Phase 3 trial proves successful. This strategic move also positions the company to potentially capture significant market share in European countries where rare disease treatments often receive favorable reimbursement considerations.

Beyond HyBryte, Soligenix's development pipeline includes expansion of synthetic hypericin into psoriasis treatment, designated as SGX302. The company is also advancing its first-in-class innate defense regulator technology, including dusquetide for inflammatory diseases and additional applications in Behcet's Disease. The company maintains a diversified portfolio through its Public Health Solutions business segment, which includes vaccine candidates for ricin toxin, filoviruses such as Marburg and Ebola, and COVID-19 prevention. These programs incorporate the company's proprietary heat stabilization platform technology, ThermoVax, and have received government funding 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.

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