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Abstracts
Ischemic
2.3. Treatment
P024 ACTISAVE study: efficacy and safety of glenzocimab on top of thrombolysis and mechanical thrombectomy
Free
  1. Martin Köhrmann1,
  2. Elie Toledano2,
  3. Yannick Plétan2,
  4. Andrea Comenducci2,
  5. Adeline Meilhoc2,
  6. Sophie Binay2,
  7. Gilles Avenard2,
  8. James Grotta3
  1. 1Essen University Hospital, University of Duisburg-Essen, Department of Neurology and Center for Translational and Behavioral Neurosciences (C-TNBS), Essen, Germany
  2. 2Acticor Biotech, Paris, France
  3. 3Memorial Hermann Hospital – Texas Medical Center, Clinical Innovation and Research Institute, Stroke Research and Mobile Stroke Unit, Houston, USA

Abstract

Introduction Glenzocimab is a monoclonal antibody fragment targeting platelet glycoprotein VI, inhibiting platelet activation and aggregation. ACTIMIS study (NCT03803007) described the safety profile of glenzocimab in AIS patients, on top of thrombolysis (IVT) with or without mechanical thrombectomy (MT), and showed a trend in efficacy measured by mRS at day-90 in patients treated by IVT and MT.

Aim of Study Glenzocimab was evaluated in ACTISAVE study (NCT05070260) for the treatment of Acute Ischemic Stroke (AIS) on top of standard of care.

Methods ACTISAVE is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, adaptive phase 2/3 study in AIS patients, treated by IVT within 4.5 hours of symptoms onset with or without MT. Patients were randomized in a 1:1 ratio and treated by an IV dose (1000 mg) of glenzocimab or placebo. Patients were also randomized according to the standard of care (SOC) received, IVT alone or IVT with MT. A subgroup analysis for patients treated with both SOC was performed.

Results Among 421 patients treated in ACTISAVE study, 159 (38%) of them received the double SOC with a recanalization assessment.

Preliminary data indicates that among patients receiving bridging therapy, median age [Q1-Q3] was 73 [65-82] with a gender proportion (F/M) of 51/49%; 78% of patients were aged ≥ 65 years, including 32% ≥ 80 years. Pre-IVT NIHSS median score [Q1-Q3] was 15 [10–20].

The optimal recanalization (eTICI 2c-3) was achieved in 107 (67%) patients.

Conclusion Unblinded results of ACTISAVE clinical trial will be available by ESMINT 2024 and presented by treatment group.

Disclosure of Interest yes JCG is a consultant for Frazer Ltd and a DSMB, advisory board member for Acticor and Prolong Pharma. MK has received speaker’s honoraria and/or compensation for advisory board participation from: Boehringer Ingelheim, Bayer, Daiichi Sankyo, Pfizer, BMS, AstraZeneca, Sanofi, Novartis, Biogen, Acticor. MK is member of the supervisory board of CompuGroup Medical SE & Co. KGaA. AC, AM, ET, SB are employees of Acticor Biotech. GA, SB and YP have management role at Acticor Biotech. AC, AM, ET, GA, SB and YP have stock interest in Acticor Biotech.

https://doi.org/10.1136/jnis-2024-ESMINT.61

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