Verseon Reports First Dosing in Phase 1 Trial on New Precision Oral Anticoagulant
05 February 2019 - 12:00AM
Business Wire
Verseon’s precision oral anticoagulants (PROACs) could become
the first anticoagulants suitable for long-term co-administration
with antiplatelet agents for the prevention of stroke and heart
attack in coronary artery disease patients.
Verseon’s phase 1 trial in healthy volunteers, which started
dosing last week, could lead to a new treatment standard for
millions of cardiac patients who would benefit from long-term
therapy with both antiplatelet and anticoagulant drugs. Current
anticoagulants (NOACs, novel oral anticoagulants) substantially
increase major bleeding events, a potentially fatal side effect,
especially when they are administered together with antiplatelet
drugs.
Preclinical studies found that Verseon’s PROACs (precision oral
anticoagulants) have similar efficacy to NOACs but with
considerably reduced bleeding, a unique combination. In particular,
PROACs have demonstrated the ability to prevent the formation of
blood clots without disrupting platelet function.
These results suggest that VE-1902, the drug candidate presently
in clinical trials, and other PROACs in Verseon’s pipeline may be
safer than current therapies when administered in combination with
one or more antiplatelet agents (e.g. aspirin, PlavixTM) for the
long-term prevention of stroke and heart attack in coronary artery
disease patients.
The ongoing phase 1 trial, which is a single-center,
double-blinded, randomized, placebo-controlled study assessing the
safety, tolerability, and composite hemostatic profile of Verseon’s
lead PROAC VE-1902, is expected to continue dosing through Q3 2019
with first results in Q4 2019.
“These new precision anticoagulants have the potential to
improve the standard of care for the millions of patients in need
of prolonged anti-clotting therapy to reduce complications
including stroke, heart attack, and bleeding,” commented Professor
Keith Fox, Duke of Edinburgh Professor of Cardiology at the
University of Edinburgh.
Verseon’s second PROAC candidate, VE-2851, is expected to enter
clinical trials later in 2019. Although VE-1902 and VE-2851 share
the same preclinical profile of clot prevention without disruption
of platelet function, they are from different chemical families.
Access to such novel chemical compounds is a key strength of
Verseon’s unique computational drug discovery platform, which has
also produced groundbreaking new drug candidates for diabetic
macular edema, hereditary angioedema, and oncology.
About the phase I trial for VE-1902
“A Study of Safety, Pharmacokinetics, and Pharmacodynamics of
Single and Multiple Ascending Oral Doses of VE-01902 in Healthy
Volunteers”
The phase 1 trial for Verseon’s first PROAC, VE-1902, (trial ID
ACTRN12618001509257) is a single-center, double-blinded,
randomized, placebo-controlled study of the safety, tolerability,
and composite hemostatic profile in 100–120 healthy volunteers.
Secondary endpoints will assess pharmacokinetic and pharmacodynamic
profiles of VE-1902. The study will include once-a-day oral dosing
in two stages: a single ascending dose stage with a food effect
cohort and a multiple ascending dose stage with 7-day repeat
dosing. The trial is being conducted at Nucleus Network in
Melbourne, Australia.
About Verseon’s PROACs
Verseon’s PRrecision Oral AntiCoagulants (PROACs) have shown
excellent efficacy in multiple preclinical studies without
disruption of platelet function. This unique feature could explain
the low bleeding of the PROACs observed in preclinical testing,
making PROACs excellent candidates for use in long-term combination
anticoagulant-antiplatelet therapy. Lead PROAC VE-1902, which is
currently in a phase I clinical trial, was well-tolerated in
regulatory toxicity studies and demonstrated low renal clearance, a
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 developing
disruptive life-science technology to advance global health. The
clinical-stage company is using its proprietary, computational drug
discovery platform paired with a comprehensive in-house chemistry
and biology workflow to build a growing drug development pipeline.
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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