Soligenix completes enrollment of patients for Phase 3 study evaluating HyBryte

Soligenix (SNGX) announced 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, or synthetic hypericin, in the treatment of cutaneous T-cell lymphoma, or CTCL. The confirmatory Phase 3 study builds on the previous statistically significant Phase 3 study, as well as a recent successful comparative study and an ongoing investigator-initiated study. FLASH2 is a randomized, double-blind, placebo-controlled, multicenter study that is enrolling approximately 80 subjects with early-stage CTCL. The study Data Monitoring Committee, or DMC, is empowered to conduct one formal Interim Analysis when approximately 60% of the total patients have completed the primary endpoint evaluation. The study replicates the double-blind, placebo-controlled design used in the first successful Phase 3 FLASH study that consisted of three 6-week treatment cycles, with the primary efficacy assessment occurring at the end of the initial 6-week double-blind, placebo-controlled treatment cycle. However, this second study extends the double-blind, placebo-controlled assessment to 18 weeks of continuous treatment 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% was observed in patients completing 18 weeks of therapy. In this second study, all important clinical study design components remain the same as in the first FLASH study, including the primary endpoint and key inclusion-exclusion criteria. The extended treatment for a continuous 18 weeks in a single cycle is expected to statistically demonstrate the effect of HyBryte(TM) over a more prolonged, “real world” treatment course.