Verseon to Initiate Phase I Study to Evaluate a New Precision Oral Anticoagulant with Reduced Bleeding Risk

FREMONT, Calif.–(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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Contacts

Verseon Corporation
Tina Schlafly
+1 (510) 225 9014
www.verseon.com
or
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Percy
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