Verseon Reports First Dosing in Phase 1 Trial on New Precision Oral Drug
Verseon’s Phase 1 trial in healthy volunteers, which recently started dosing, 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 now 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 (eg, aspirin, Plavix) 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.
Professor Keith Fox, Duke of Edinburgh Professor of Cardiology at the University of Edinburgh, said “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.”
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.
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.
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 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. For more information, visit www.verseon.com.
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