CureGene Pharmaceutical has dosed the first participant in its pivotal clinical trial of Evategrel (CG-0255), a next-generation antiplatelet therapy, in the US.
This marks a significant milestone in the clinical development of Evategrel and advances CureGene’s plans to submit a new drug application (NDA) in the country.
Evategrel, CureGene’s lead asset developed through its A-proX Prodrug platform, is the first purinergic receptor P2Y, G-protein coupled, 12 (P2Y12) receptor inhibitor available in both intravenous and oral forms.
Utilising a thiol-hydrolysing prodrug design, Evategrel is activated by hydrolases, which are widely distributed in human tissues, and bypasses the cytochrome P450 (CYP450) enzyme pathway.
This approach aims to overcome issues such as clopidogrel resistance, slow onset of action, patient variability, and drug-drug interaction risk.
The ongoing US registrational trial will assess the safety and efficacy of Evategrel in both injection and oral capsule formulations.
It will compare Evategrel to clopidogrel in participants with acute coronary syndrome, recent myocardial infarction, ischaemic stroke, and peripheral arterial disease. The findings will support regulatory submissions worldwide.
The agent is reportedly suitable for elderly patients with comorbidities, due to minimal drug-drug interaction potential.
CureGene Pharmaceutical founder and CEO Dr Gongxin said: “The first participant dosing in our US pivotal trial of Evategrel is a major milestone in CureGene’s journey of global innovative drug R&D.
“Cardiovascular and cerebrovascular diseases remain the leading cause of mortality and disability worldwide, and current treatment options have substantial unmet needs.
“With its novel mechanism of action and dual-formulation advantages, Evategrel is expected to reshape the global landscape of antiplatelet therapy.”
Alongside this trial in the US, Evategrel is progressing in China, where CureGene has received approval for a Phase II trial for ischaemic stroke. This parallel development supports future simultaneous NDA submissions and global market entry preparations.
Evategrel is in late-stage clinical development and is expected to seek regulatory approval as early as 2027.
