Verseon to Initiate Phase I Study to Evaluate a New Precision Oral Anticoagulant with Reduced Bleeding Risk
14 June 2018 - 6:55PM
Business Wire
Verseon will be starting 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, 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.
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 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 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.
About Verseon’s anticoagulation program
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.
About Verseon
Verseon Corporation (www.verseon.com, AIM: VSN) is 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.
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