Verseon Corporation Verseon commences anticoagulant phase I trial (6153A)
13 9월 2018 - 3:00PM
UK Regulatory
TIDMVSN
RNS Number : 6153A
Verseon Corporation
13 September 2018
Press release September 13, 2018
Verseon Corporation
("Verseon" or the "Company")
Verseon commences phase I trial for precision oral anticoagulant
VE-1902
Fremont, Calif.-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
-------------------- ----------------------------------------------------------
Primary endpoint To assess the safety, tolerability, and composite
hemostatic activity of VE-1902 after single
and multiple oral dosing in healthy volunteers
-------------------- ----------------------------------------------------------
Secondary endpoints 1. To determine the pharmacokinetic profile
of VE-1902 after single and multiple oral dosing,
including exposure, dose proportionality, and
food effect
2. 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 (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-
For further information, please contact
Verseon Corporation www.verseon.com
Sebastian Wykeham +1 (510) 225 9000
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+44 (0) 20 7614
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END
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