Feb 04, 2019
Fremont, Calif.—Verseon, the clinical-stage pharmaceutical company developing disruptive life-science technology to advance global health, announces that dosing has started in the phase I clinical trial of VE-1902, the Company’s leading candidate for a new class of PRecision Oral AntiCoagulants (PROACs). Preclinical data suggest that 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 (CAD) patients.
Anticoagulants, commonly referred to as blood thinners, are used to prevent stroke and venous thromboembolism. However, current anticoagulants substantially increase major bleeding events, a potentially fatal side effect, especially when they are administered together with antiplatelet drugs (e.g., aspirin, PlavixTM). As a result, current treatment guidelines generally do not recommend combined anticoagulant-antiplatelet treatment for longer than twelve months.
In preclinical testing, PROACs have shown a unique combination of efficacy with lower bleeding. In particular, PROACs have demonstrated the ability to prevent the formation of blood clots without disrupting platelet function. These results suggest that VE-1902 and other PROACs in Verseon’s pipeline may be safer alternatives than currently available therapeutics when administered in combination with one or more antiplatelet agents.
The ongoing phase I 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.
“The start of subject dosing is an exciting milestone for Verseon,” said Dr. David Kita, Verseon’s VP of R&D.; “PROACs have the potential to change the standard of care for millions of CAD patients who would benefit from long-term combination therapy with antiplatelet drugs. We look forward to the results of VE-1902 in this first-in-human trial.”
“A Study of Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of VE-01902 in Healthy Volunteers”
The phase I 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.
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.
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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