Market Overview

Verseon Commences Phase I Trial for Precision Oral Anticoagulant VE-1902


Verseon, a technology-based pharmaceutical company, today announces that
it has received ethics committee approval and acknowledgement from the
Therapeutic Goods Administration in Australia for the phase I clinical
trial of VE-1902, the first clinical candidate from its novel class of
precision oral anticoagulants (PROACs). Verseon's PROACs, in preclinical
testing, show a unique combination of efficacy with low bleeding,
potentially making them suitable for stroke prevention in atrial
fibrillation or prolonged co-administration with antiplatelet drugs for
patients with coronary artery disease.

The primary goal of this double-blinded, randomized, placebo-controlled
phase I trial is to study the safety, tolerability, and composite
hemostatic profile of VE-1902 in healthy volunteers. Secondary endpoints
will assess pharmacokinetic and pharmacodynamic profiles. The study will
be conducted in two stages investigating once-a-day oral dosing in
tablet form: a single ascending dose stage with a food effect comparison
cohort and a multiple ascending dose stage with 7-day repeat dosing.

"Verseon's precision oral anticoagulants provide an exciting opportunity
to develop a safe approach to long-term combination therapy with
antiplatelet drugs to reduce strokes and heart attacks in patients with
coronary artery disease," said Professor John Deanfield, Professor of
Cardiology at University College London.

"The clinical evaluation of VE-1902 is an important step in bringing
safer anti-thrombotic treatment to patients worldwide," said Adityo
Prakash, CEO of Verseon. "We look forward to clinical trial results from
this program and from others in our growing drug development pipeline."

Clinical Appendix

Trial ID       ACTRN12618001509257
Study title       A Study of Safety, Pharmacokinetics, and Pharmacodynamics of Single
and Multiple Ascending Oral Doses of VE-01902 in Healthy Volunteers.


      To assess the safety, tolerability, and composite hemostatic
activity of VE-1902 after single and multiple oral dosing in healthy


      To determine the pharmacokinetic profile of VE-1902 after single and
multiple oral dosing, including exposure, dose proportionality, and
food effect.

To determine the pharmacodynamic profile of VE-1902 after single
and multiple oral dosing, including the effect of VE-1902 on
coagulation and platelet activation.

Study design       A single-center, double-blinded, randomized, placebo-controlled,
single ascending dose study with food effect crossover and multiple
ascending dose study to investigate the safety, tolerability,
pharmacokinetic, pharmacodynamic, and hemostatic profile of VE-1902
in healthy volunteers. Up to seven single dose cohorts and five
repeat dose cohorts will be evaluated.
Population       Healthy male and female adult volunteers age 18–45 years.
Trial location       Nucleus Network, Melbourne, Victoria, Australia.

About Verseon's PROACs

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. VE-1902, currently undergoing a phase I clinical trial, 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 (,
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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