Soligenix Reaches Interim Enrollment Milestone in Phase 3 HyBryte Trial for CTCL

Reuters
2025.11.19 12:30
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Soligenix Inc. has completed patient enrollment for the interim analysis of its Phase 3 HyBryte trial for CTCL, reaching a milestone with 50 out of 80 patients enrolled. The interim analysis is set for Q2 2026, with a current blinded study response rate of 48%, surpassing the initial 25% estimate. Topline results are expected in H2 2026.

Soligenix Inc. has announced the completion of patient enrollment for the planned interim analysis in its confirmatory Phase 3 clinical trial of HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL). The trial, known as FLASH2, has enrolled 50 out of a total 80 patients, reaching a key milestone for the interim analysis, which is scheduled to occur in the second quarter of 2026. The company reports that the overall blinded study response rate to date is 48%, exceeding the initial estimate of 25%. Topline results from the study are expected in the second half of 2026. Results from this trial have not yet been presented. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Soligenix Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: PH28139) on November 19, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)