Soligenix Reports Positive Data from HyBryte Phase 3 Study in CTCL.

Soligenix, a biopharmaceutical company, has announced that its first Data Monitoring Committee meeting for its confirmatory Phase 3 study of HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) has concluded that there are no safety concerns and an acceptable safety profile. The study is on track for a 4Q2025 enrollment update and a targeted 1H2026 interim efficacy analysis.

Soligenix, Inc. (Nasdaq: SNGX) announced today that its Data Monitoring Committee (DMC) meeting for the confirmatory Phase 3 study evaluating HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) has concluded. The DMC found no safety concerns and confirmed that HyBryte™ has an acceptable safety profile consistent with prior clinical studies. The study, named FLASH2, is on track to provide an enrollment update in the fourth quarter of 2025 and a targeted interim efficacy analysis in the first half of 2026.

The FLASH2 study is a randomized, double-blind, placebo-controlled, multicenter trial enrolling approximately 80 subjects with early-stage CTCL. It replicates the design of the first successful Phase 3 FLASH study, with the primary efficacy assessment occurring at the end of an 18-week continuous treatment period. The study aims to demonstrate the effectiveness of HyBryte™ over a more prolonged treatment course, potentially offering a safer and more effective treatment option for patients with CTCL.

HyBryte™, a first-in-class photodynamic therapy using safe, visible light for activation, has shown promising results in previous studies. In the initial Phase 3 FLASH trial, a treatment response of 49% was observed in patients receiving HyBryte™ compared to 4% in the placebo group (p0.0001). The study also demonstrated that HyBryte™ is safe and well-tolerated, with no systemic availability, making it a potentially safer alternative to existing therapies.

Soligenix anticipates providing an update on enrollment progress and the blinded aggregate response rate before the end of 2025. The company is committed to completing the study on schedule and expects topline results in the second half of 2026.