Soligenix, Inc. announced on November 19, 2024, the formation of a European Medical Advisory Board (MAB) to provide strategic guidance for its confirmatory Phase 3 study of HyBryte™ in cutaneous T-cell lymphoma (CTCL). This MAB comprises internationally renowned physicians with extensive experience in treating CTCL.
The confirmatory 18-week study is expected to enroll approximately 80 patients across the United States and Europe, with patient enrollment targeted to begin by the end of 2024. Top-line results from this pivotal trial are anticipated in the second half of 2026.
The European MAB will offer feedback and guidance on clinical strategies, implementation, health economics, and reimbursement, complementing the existing U.S. MAB. This initiative underscores Soligenix's commitment to advancing HyBryte™ toward potential worldwide marketing authorizations.
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