Soligenix Expands European MAB To Provide Addl Medical/Clinical Strategic Guidance As It Advances Confirmatory Phase 3 Placebo-Controlled Study Evaluating Safety And Efficacy Of HyBryte In CTCL Treatment

Author: Benzinga Newsdesk | September 30, 2025 06:36am

In preparation for health authority interactions in pursuit of marketing approvals in Europe  

PRINCETON, N.J., Sept. 30, 2025 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today the expansion of its European Medical Advisory Board (MAB) to provide additional medical/clinical strategic guidance to the Company as it advances its confirmatory Phase 3 multicenter, double-blind, placebo-controlled study evaluating the safety and efficacy of HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) patients with early-stage disease. This confirmatory, 18-week study is expected to enroll approximately 80 patients and is targeted to report top-line results in the second half of 2026.

Comprised of internationally renowned physicians with extensive experience in treating and running clinical research trials in CTCL, this esteemed expanded MAB will play an important advisory role in the conduct and interpretation of the upcoming Phase 3 clinical study and the associated regulatory interactions with health authorities. The MAB will provide expert feedback, input, and guidance on clinical strategies and their implementation, as well as on other critical items, such as health economics and reimbursement, to assist Soligenix in meeting the needs of patients suffering from CTCL.

Posted In: SNGX