Jun 14, 2018
Fremont, Calif.—Verseon, a technology-based pharmaceutical company, today provides an update on preparations for a first-in-human phase I trial in Australia for its lead-PROAC (PRecision Oral AntiCoagulant), VE‑1902, which has successfully completed regulatory toxicology studies and was well-tolerated in 28-day repeat dosing.
Verseon’s 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, Verseon believes that 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. This is particularly relevant for the tens of millions of patients worldwide with acute coronary syndrome or non-valvular atrial fibrillation comorbid with coronary artery disease.
Professor 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, through its wholly owned subsidiary VCR1, will submit an application to the Australian Human Research Ethics Committee and expects to initiate participant recruitment shortly after approval by the Therapeutic Goods Administration. To carry out the study, VCR1 is working closely with phase-I unit Nucleus Networks© and full-service contract research organization 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.
“Nucleus Networks© is the largest phase I unit in Australia and has completed over 500 trials since 2003,” commented Cameron Johnson, CEO and Managing Director at Nucleus Networks©. “We are delighted to support Verseon with our extensive clinical-trial experience and infrastructure as they aim to establish the unique profile of VE‑1902 in humans.”
Verseon’s precision oral anticoagulants (PROACs) are potent, highly selective, reversible covalent inhibitors of thrombin. PROACs have shown excellent efficacy in multiple preclinical studies but do not disrupt platelet function. This unique feature could explain the low bleeding risk of these precision anticoagulants and makes them excellent candidates for use in long-term combination anticoagulant-antiplatelet therapy. The lead PROAC VE‑1902 is scheduled to enter clinical trials in mid-2018. VE‑1902 was well-tolerated in regulatory tox studies and has demonstrated very low renal clearance, a highly desirable property for patients with impaired kidney function. A second PROAC is expected to enter the clinic in 2019.
Verseon Corporation (www.verseon.com, AIM: VSN) s a technology-based pharmaceutical company that pairs a proprietary, computational drug discovery platform with a comprehensive in-house chemistry and biology workflow to develop novel therapeutics that are unlikely to be found using conventional methods. The Company is applying its platform to a growing drug pipeline and currently has four active drug programs in the areas of anticoagulation, diabetic macular edema, hereditary angioedema, and oncology. The anticoagulation program is scheduled to enter phase I clinical trials in 2018.
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