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Verseon submits phase I protocol for VE-1902

18th Jul 2018 07:00

RNS Number : 9359U
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.

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For further information, please contact

Verseon Corporation

www.verseon.com

Sebastian Wykeham / Tina Schlafly

+1 (510) 225 9000

 

 

Cenkos Securities (NOMAD and Joint Broker)

 

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 +44 (0) 20 7397 8900

 

 

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Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook," and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions, and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact [email protected] or visit www.rns.com.
 
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