On Monday, Soligenix, Inc. (NASDAQ:SNGX) said it has opened patient enrollment for its confirmatory Phase 3 study evaluating HyBryte (synthetic hypericin) for cutaneous T-cell lymphoma (CTCL).
The confirmatory Phase 3 study, FLASH2, builds on the previous statistically significant Phase 3 (FLASH) study, as well as a recent comparative study (HPN-CTCL-04) and an ongoing investigator-initiated study, each further supporting the design of the FLASH2 clinical trial.
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The FLASH2 study is expected to enroll patients in the U.S. and Europe, and a formal interim analysis is anticipated early in 2026.
The company looks forward to providing periodic updates on the trial's progress in 2025
FLASH2 will enroll approximately 80 subjects with early-stage CTCL, a group of rare blood cancers that affect the skin.
The study replicates the double-blind, placebo-controlled design used in the first Phase 3 FLASH study, which consisted of three 6-week treatment cycles (18 weeks total). The primary efficacy assessment occurred at the end of the initial 6-week cycle (Cycle 1).
However, this second study extends to 18 weeks of continuous treatment (no "between-cycle" treatment breaks), with the primary endpoint assessment occurring at the end of the 18-week timepoint.
In the first Phase 3 study, a treatment response of 49% (p<0.0001 vs patients receiving placebo in Cycle 1) was observed in patients completing 18 weeks (3 cycles) of therapy.
The extended treatment for a continuous 18 weeks in a single cycle is expected to statistically demonstrate the effect of HyBryte over a more prolonged, "real world" treatment course.
In July, Soligenix shared an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte treatment for up to 12 months in patients with early-stage CTCL.
Price Action: SNGX stock closed at $3.14 on Friday.
