Progress update on the phase II, double-blinded, randomised, placebo-controlled study to determine the safety, preliminary efficacy and pharmacokinetics of arg-007 in acute ischemic stroke patients (SEANCON).

Abstract

Background: ARG-007 is a cationic poly-arginine peptide consisting of 18 D-arginine residues that is being developed as a cerebroprotective agent in acute ischemic stroke. Extensive pre-clinical studies, a Phase 1 first-in-human study and the plan for the proof-of-concept Phase 2 study in acute ischemic patients (SEANCON) have previously been presented previously at Stroke Society of Australasia (now Australia New Zealand Stroke Organisation, ANZSO). Aim(s): To provide an update on recruitment and progress of the Phase 2 study. Method(s): This trial is a double-blind, placebo-controlled randomised Phase 2 trial. The latest data on screening, recruitment and safety is provided at the time of submission of the abstract, and then updated at the time of presentation. The trial is registered on ANZCTR (ACTRN12623001110673). Result(s): Site selection was finalised by December 2023, with the first 3 sites activated by March 2024 and the remaining 8 sites soon thereafter. The first participant was randomised in March 2024. A total of 10 subjects have been randomised as of May 10, 2024. The independent Data Safety Monitoring Board (DSMB) met for the first time on 22 April, reviewing the first 5 participants. No major issues were identified with the DSMB recommending the trial continued unchanged. Conclusion(s): Early enrolment has progressed well, with no major safety issues identified.