The first-in-human phase I trial will take place in Australia for Verseon’s PROAC (PRecision Oral AntiCoagulant) VE-1902, which has successfully completed regulatory toxicology studies and was well-tolerated in 28-day repeat dosing.
PROACs are a novel class of anticoagulants that show efficacy comparable to the NOACs (novel oral anticoagulants) but much-reduced bleeding in preclinical studies. Because of this unique profile, PROACs could have a major impact on the cardiovascular disease market by becoming the first oral anticoagulants suitable for long-term anticoagulant-antiplatelet combination therapy. Such treatment is particularly relevant for tens of millions of patients worldwide with acute coronary syndrome or non-valvular atrial fibrillation comorbid with coronary artery disease.
Keith Fox, Duke of Edinburgh Professor of Cardiology at the University of Edinburgh, commented, “If Verseon’s promising preclinical results translate to benefits in the clinic, these new precision anticoagulants could improve the standard of care for the millions of patients who need prolonged anti-clotting therapy to reduce major adverse cardiac complications.”
“An oral anticoagulant that can be safely co-administered with antiplatelets has been an elusive goal for the global health community for many years due to the high bleeding risk of the NOACs. We believe that our PROACs could be a real lifesaver for a very large, global patient population,” said Eniko Fodor, COO and CFO at Verseon. “We have chosen Australia for our phase I trial because of its excellent clinical trial infrastructure and research incentives. This should allow us to conduct high-quality trials in a cost-effective manner.”
For the phase I trial of VE-1902, Verseon will submit an application to the Australian Human Research Ethics Committee and plans to initiate participant recruitment shortly after receiving approval by the Therapeutic Goods Administration. To carry out the study, Verseon is working closely with phase I unit Nucleus Networks and full-service contract research organisation CPR Pharma Services. Nucleus Networks will provide bed space, clinical staff, and sample collection, and CPR Pharma Services will provide oversight, data management, and biostatistics.