PR Newswire·Sep 30, 2025, 7:30 AM ET

Soligenix Announces Expansion of European Medical Advisory Board for Cutaneous T-Cell Lymphoma

SNGX

Soligenix expanded its European Medical Advisory Board (MAB) to five members, including new additions Drs. Julia Scarisbrick and Maarten Vermeer, to guide marketing approval efforts in the EU and UK.
The company is advancing a confirmatory Phase 3 study named FLASH 2 for HyBryte™ (synthetic hypericin) to treat early-stage cutaneous T-cell lymphoma (CTCL).
The FLASH 2 study is an 18-week, multicenter, double-blind, placebo-controlled trial targeting enrollment of approximately 80 patients with top-line results expected in the second half of 2026.
The study design replicates the first FLASH trial but extends the double-blind assessment to 18 weeks of continuous treatment without breaks, aiming to demonstrate efficacy over a prolonged real-world course.
HyBryte™ is a first-in-class photodynamic therapy using synthetic hypericin activated by visible light, which avoids DNA damage risks associated with ultraviolet-based treatments.
Previous Phase 3 FLASH trial data showed a 16% response rate for HyBryte™ versus 4% for placebo in Cycle 1, with response rates increasing to 40% for 12-week treatment and 49% for 18-week treatment in subsequent cycles.
The FDA and EMA previously indicated that a second successful Phase 3 trial is required for marketing approval, with the EMA agreeing to the current study design while the FDA expressed a preference for a longer duration comparative study.
HyBryte™ has received orphan drug and fast track designations from the FDA, along with orphan designation from the EMA.
Soligenix also secured a $2.6 million Orphan Products Development grant from the FDA to support an investigator-initiated study evaluating HyBryte™ for home use in early-stage CTCL patients.
CTCL is a rare non-Hodgkin's lymphoma affecting an estimated 31,000 individuals in the US and 38,000 in Europe, with no current cure or approved front-line therapy available.