Veralox Therapeutics Announces EMA Orphan Drug…

Frederick, MD., Aug. 14, 2024 -- Veralox Therapeutics, a clinical-stage biotechnology company developing first-in-class therapies targeting the 12-lipoxygenase (12-LOX) pathway, announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to VLX-1005, a small molecule 12-LOX inhibitor for the treatment of platelet-activating anti-platelet factor 4 (PF4) disorders. VLX-1005 previously secured ODD from the U.S. Food and Drug Administration for prophylaxis of thrombosis in patients with heparin-induced thrombocytopenia (HIT) as well as FDA Fast Track Designation. This latest decision in Europe represents another regulatory achievement and builds on the successful development of VLX-1005 that has progressed through completed Phase 1 clinical studies, and into the ongoing Phase 2 trial ALATHEA (“A study of VLX-1005 to evaluate thrombocyte change in HEpArin-induced thrombocytopenia”).