Verseon Corporation Verseon submits phase I protocol for VE-1902
2018年7月18日 - 3:00PM
RNSニュース (英語)
TIDMVSN
Verseon Corporation
18 July 2018
July 18, 2018
Verseon Corporation
("Verseon" or the "Company")
Verseon submits phase I protocol for precision oral
anticoagulant VE-1902 to regulatory authorities
Fremont, Calif.-Verseon, a technology-based pharmaceutical
company, today announces that it has submitted a phase I clinical
trial protocol for VE-1902, its lead PROAC (precision oral
anticoagulant), to the Bellberry Human Research Ethics Committee
(HREC) in Australia. The proposed study is a double-blinded,
randomized, placebo-controlled phase I trial to assess the safety
and tolerability of VE--1902 tablets in healthy volunteers with
once-a-day oral dosing. The phase I trial is expected to start in
Q3 2018, after approval by the HREC and acknowledgment by the
Therapeutic Goods Administration.
VE-1902 is the first clinical candidate from Verseon's novel
class of PROACs, which have shown good 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 may allow PROACs to become the first
oral anticoagulants suitable for long-term
anticoagulant-antiplatelet combination therapy.
"VE-1902 has continued to demonstrate its excellent profile in
preclinical testing and successfully completed all regulatory
studies leading up to today's submission for first-in-human
clinical trials," said Dr. David Kita, Vice President of R&D at
Verseon. "We are looking forward to confirming its distinctive
profile in human trials."
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. 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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