FREMONT, Calif.--(BUSINESS WIRE)--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.”
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Clinical Appendix |
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| 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. | |||
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Primary |
To assess the safety, tolerability, and composite hemostatic activity of VE-1902 after single and multiple oral dosing in healthy volunteers. | |||
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Secondary |
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. |
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| 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.
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