Soligenix has announced that the Data Monitoring Committee completed the interim efficacy analysis of its pivotal Phase 3 FLASH2 (Fluorescent Light Activated Synthetic Hypericin 2) trial evaluating HyBryte (Synthetic Hypericin) in the treatment of Cutaneous T-Cell Lymphoma (CTCL). Under the terms of the interim analysis, the study was recommended to halt for futility.  

Dr. Christopher J. Schaber, P.hD, President and Chief Executive Officer, Soligenix, stated, "We are obviously very disappointed with the unanticipated outcome of the study. Despite the fact that HyBryte demonstrated statistically significant reductions in CTCL lesions after six weeks’ treatment in the first FLASH study, a similar signal was not observed with 18 weeks of treatment in this study. Over the coming weeks, we will analyse the data to better determine why the study did not meet expectations. If there is any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from HyBryte therapy, then we intend to communicate our findings and explore follow-up discussions with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

"With approximately USD 5.9 million of cash, we will evaluate all strategic options moving forward, including but not limited to merger and acquisition opportunities as well as the potential of advancing dusquetide for the treatment of Behçet's Disease, which demonstrated promising biological efficacy in a Phase 2 study last year using the intravenous formulation and has received Orphan Drug Designation most recently from the EMA," he continued.