Poster Presentation Asia Pacific Stroke Conference 2024

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) (#453)

David J Blacker 1 2 3 4 , Meghan G Thomas 5 , Tim Phillips 1 6 , Paul Bailey 1 7 , Geoffrey Donnan 1 8 , Jeffrey L Saver 1 9 , Liz Dallimore 5 , Samantha South 5 , Neville W Knuckey 2 10 11 , Bruno P Meloni 2 5 10 11 , Darshan Ghia 4 12 , Thomas Chemmanam 3 , Andrew Cheung 13 14 15 , Dennis Cordato 13 14 15 , Christopher Levi 16 17 , Henry Ma 18 , Bruce Campbell 19 , Michael Devlin 20 , Andrew Wong 21 22 , Peter Bailey 23 , Timothy Kleinig 24 , Graeme J Hankey 2 25
  1. Clinical Advisory Committee, Argenica Therapeutics, Nedlands, WA, Australia
  2. Perron Institue for Neurological and Translational Science, Nedlands, WA, Australia
  3. Neurology, Sir Charles Gairdner Hospital, Nedlands, WA, Australia
  4. Medicine and Pharmacology, University of Western Australia, Crawley, WA, Australia
  5. Argenica Therapeutics, Nedlands, WA, Australia
  6. Neurological Intervention and Imaging Service Western Australia, Sir Charles Gairdner Hospital, Fiona Stanley Hospital and Perth Children's Hospital, Perth, WA, Australia
  7. Emergency Medicine, WA Country Health Service, Perth, WA, Australia
  8. Melbourne Brain Centre, The Royal Melbourne Hospital, The University of Melbourne, Parkville, VIC, Australia
  9. Department of Neurology, University of California, Los Angeles, United States of America
  10. Centre for Neuromuscular and Neurological Disorders, The University of Western Australia, Nedlands, WA, Australia
  11. Department of Neurosurgery, Sir Charles Gairdner Hospital, Nedlands, WA, Australia
  12. Department of Neurology, Fiona Stanley Hospital, Murdoch, WA, Australia
  13. Department of Interventional Neuroradiology, Liverpool Hospital, Liverpool, NSW, Australia
  14. South Western Sydney Clinical School, University of New South Wales, Liverpool, NSW, Australia
  15. Ingham Institute for Applied Medical Research, Liverpool, NSW, Australia
  16. Department of Neurology, John Hunter Hospital, Newcastle, NSW, Australia
  17. School of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia
  18. Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences, Monash Health, Melbourne, VIC, Australia
  19. Melbourne Brain Centre, The Royal Melbourne Hospital, The University of Melbourne, Parkville, VIC, Au
  20. Department of Neurology and Stroke, Princess Alexandra Hospital, Woolloongabba, QLD, Australia
  21. Department of Neurology and Stroke, Royal Brisbane and Women's Hospital, Herston, QLD, Australia
  22. Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia
  23. Department of Neurology, Gold Coast University Hospital, Southport, QLD, Australia
  24. Department of Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia
  25. Medical School, University of Western Australia, Nedlands, WA, Australia

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).

Aims

To provide an update on recruitment and progress of the Phase 2 study.

Methods

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).

Results

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.

Conclusions

Early enrolment has progressed well, with no major safety issues identified.