Verseon’s phase 1 trial in healthy volunteers, which started dosing last week, 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 presently 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 (e.g. aspirin, PlavixTM) 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.
“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,” commented Professor Keith Fox, Duke of Edinburgh Professor of Cardiology at the University of Edinburgh.
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.