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”).

“This EMA designation is an important step forward in the development of VLX-1005 in addressing serious diseases caused by platelet-activating anti-PF4 disorders such as HIT,” said Michael Hanna, M.D., Chief Medical Officer of Veralox Therapeutics. “This is a significant regulatory milestone for Veralox and is an important acknowledgement of the potential of VLX-1005 as treatment for HIT.”

HIT is a serious, potentially life-threatening platelet disorder that can arise after taking the blood thinner heparin, which by American Heart Association and European Society of Cardiology guidelines is the standard-of-care anticoagulant for many cardiovascular procedures. Heparin is commonly used to prevent blood clots following heart surgeries, cardiopulmonary bypass and many other procedures such as kidney dialysis. In rare cases, heparin triggers a reaction that activates platelets, consuming them in a process that lowers platelet counts (thrombocytopenia) to unsafe levels while promoting clot formation, which then increases the risk for potentially fatal or life-threatening thromboembolic events. Between one quarter and one third of those who develop HIT die from the condition and a significant proportion of patients develop new blood clots, which could result in deep vein thrombosis, pulmonary embolism, heart attack or stroke.

VLX-1005 has successfully completed Phase 1 clinical trials and has demonstrated a favorable safety and tolerability profile and preferred pharmacokinetics in healthy participants and is currently enrolling patients in the Phase 2 clinical study.

 

Source: globenewswire.com

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