Verseon Corporation Verseon preparing for anticoagulant phase I trial (3304R)
14 June 2018 - 4:00PM
UK Regulatory
TIDMVSN
RNS Number : 3304R
Verseon Corporation
14 June 2018
June 14, 2018
Verseon Corporation
("Verseon" or the "Company")
Verseon preparing for phase I study in Australia to evaluate a
new anticoagulant with reduced bleeding risk
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(c) and full-service contract
research organization CPR Pharma Services(c). Nucleus Networks(c)
will provide bed space, clinical staff, and sample collection, and
CPR Pharma Services(c) will provide oversight, data management, and
biostatistics.
"Nucleus Networks(c) 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(c) . "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."
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.
-Ends-
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END
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