Soligenix Completes Planned Enrollment Of 50 Patients Necessary For Interim Analysis In 80 Patient Confirmatory Phase 3 Double-Blind, Placebo-Controlled Study Evaluating HyBryte In CTCL Treatment

Author: Benzinga Newsdesk | November 19, 2025 07:33am

• 50 of 80 patients enrolled in FLASH2 study
   
•  Blinded Response Rate to Date Exceeds Trial Estimate

PRINCETON, N.J., Nov. 19, 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 that it has completed the planned enrollment of 50 patients necessary for the interim analysis in its 80 patient confirmatory Phase 3 double-blind, placebo-controlled study evaluating HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL). The confirmatory Phase 3 study (Fluorescent Light Activated Synthetic Hypericin 2, FLASH2), builds on the previous statistically significant Phase 3 (FLASH) study, as well as a recent successful comparative study (HPN-CTCL-04) and an ongoing investigator-initiated study .

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