Abstract Number: Esoc2026a419 Final Results of the Phase Ii Arg-007-002 Seancon Trial of Arg-007 in Acute Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy
Year: 2026
Type: conference-abstract
Abstract: Background and aims The Phase II SEANCON study aimed to evaluate the safety, tolerability, and preliminary efficacy of a single intravenous dose of ARG-007 (a cationic poly-arginine peptide with cerebroprotective effects in preclinical models) in patients with AIS undergoing revascularisation by endovascular thrombectomy. Methods SEANCON was a multicentre, randomized, double-blind, placebo-controlled trial conducted at 10 Australian stroke centres. Large vessel occlusion AIS patients, eligible for endovascular thrombectomy within 24 hours of symptom onset, were enrolled and randomized 1:1 to ARG-007 or placebo. Enrolment criteria included baseline NIHSS > 5 and prestroke mRS 0–3, site-assessed ASPECTS 0–5 were excluded. All participants received standard-of-care thrombectomy with/without intravenous thrombolysis. The primary outcomes were measures of safety. The secondary outcome was infarct volume at 48 hours. Results 93 participants were randomized (ARG-007 n = 46; placebo n = 47). Follow-up to day 90 was completed by 77 (83%) participants; 16 (17%) participants died before day 90. There was no significant difference between treatment groups in treatment-emergent adverse events (risk ratio [RR]:1.02, 95% CI: 0.91-1.15; P = 0.72), mortality at day 90 (RR:1.70, 0.67-4.30, P = 0.26), symptomatic intracranial hemorrhage (RR:4.09, 0.47-35.2, P = 0.20), worsening of the index stroke (RR:2.04, 0.76-5.52, P = 0.16), or functional independence at day 90 (mRS 0-2: odds ratio 0.92, 0.36-2.37, P = 0.86). Infarct volume at 48 hours did not differ significantly between groups (ratio (adjusted): 1.65, 0.97–2.81, P = 0.065). A potential subgroup signal favoring ARG-007 was observed in participants with poor collateral circulation. Conclusions In AIS patients, ARG-007 was safe and well tolerated. Conflict of interest David Blacker: Shareholder in Argenica Therapeutics Ltd and is paid a consultancy fee as Chair of the Argenica Clinical Advisory Committee. All other authors have nothing to disclose.
Source: European Stroke Journal
Institutions: The University of Western Australia, Perron Institute for Neurological and Translational Science, Gold Coast Hospital, The Royal Melbourne Hospital, The University of Melbourne, Sir Charles Gairdner Hospital, Liverpool Hospital, Princess Alexandra Hospital, Fiona Stanley Hospital, Royal Adelaide Hospital, John Hunter Hospital, Newcastle University
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,400
OpenAlex ID: W7160441890
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