“While we continue our ongoing discussions with the United States (U.S.) Food and Drug Administration (FDA), we shared that the European Medicines Agency (EMA) has agreed to the study design of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) patients with early-stage disease. This study will enroll approximately 80 patients across the U.S. and Europe, starting before the end of 2024, with top-line results expected in the second half of 2026. We also will be initiating a Phase 2 study with SGX945 (dusquetide) in Behçet’s disease later this year with top-line results expected in the first half of 2025, along with top-line results expected during the same timeframe from our ongoing SGX302 (synthetic hypericin) Phase 2 study in mild-to-moderate psoriasis.”
Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix
“We have a clear vision for the future, and we are actively pursuing new opportunities to create long-term value for our shareholders including but not limited to, partnership and merger and acquisition opportunities.”
Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix