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- New analyses of ACTISAVE phase 2/3 study show positive trends for glenzocimab in subpopulations of patients
- Continuation of clinical studies: Phase 2/3 GREEN in Ischemic stroke and Phase 2b LIBERATE in myocardial infarction
- Launch of GALICE, a Phase 2/3 study in severe ischemic stroke, sponsored by the Hôpital Fondation Adolphe de Rothschild and funded by a public grant (national PHRC1 in 2023)
Gilles Avenard, Chief Executive Officer, explains: " We are pleased with the additional analyses carried out on the ACTISAVE study and with the opinion from scientists and clinicians. This reinforces our conviction that, despite the results presented at ESOC, glenzocimab still has a place in the treatment of cardiovascular emergencies in particular in the treatment of the acute phase of ischemic stroke. The spectacular evolution in patient management since the advent of thrombectomy should encourage us to be more precise in selecting patients likely to benefit from new treatments, and reminds us of the heterogeneity of this pathology, both in terms of aetiology and because of the extreme disparity of patients. The search for partners is now our priority to pursue product development, discussions have been initiated in this way."
Clinical development plan in the acute phase of ischemic stroke
ACTIMIS and ACTISAVE: 2 clinical studies conducted by
The Company has conducted and completed two clinical studies in the treatment of acute stroke:
- ACTIMIS, a Phase 1b/2a study with glenzocimab in ischemic stroke, showing positive results presented at scientific congresses in 2022 and 2023 and published in the Lancet Neurology journal in
February 2024 . - ACTISAVE, a Phase 2/3 efficacy study, that recruited from 7 European countries in
Europe ,Israel , theUK and theUSA . The results of the 400-patient ACTISAVE trial were presented at theEuropean Congress (ESOC) inMay 2024 .
The negative results of ACTISAVE on the primary and secondary endpoints led the Company to conduct analyses on patient sub-populations showing positive trends for glenzocimab on the mRS 0-1 score (pre-specified analysis), i.e., a return to normal life, the endpoint recommended by the FDA.
These analyses identified an imbalance in several key factors at inclusion likely to explain why the reference treatment was seemingly outperforming glenzocimab, particularly in patients treated by mechanical thrombectomy in addition to thrombolysis. This imbalance concerned the percentage of diabetic patients, whose ultimate prognosis is poorer, the severity score at inclusion (NIHSS) and the respective administration times of the reference treatment and glenzocimab. A post-hoc statistical analysis with an adjustment for these imbalanced prognostic factors showed a much more favorable result for glenzocimab on the mRS 0-1 score. It was also shown that patients with concomitant antithrombotic had a better outcome in the glenzocimab group, as did fully recanalized patients (eTICI 3) after mechanical thrombectomy and patients with a high severity score at inclusion.
In addition, it should be noted that the ACTIMIS and ACTISAVE studies can hardly be compared on several criteria, including patient severity at inclusion, overall evolution of stroke management, and percentage of patients with intracerebral hemorrhage leading to death.
Considering the results of these two studies, glenzocimab continues to be an attractive candidate for the treatment of the acute phase of ischemic stroke. The Company therefore intends to pursue the development of glenzocimab in this indication, particularly in patients eligible to thrombectomy and in very severe ones.
Finally, numerous world leading experts in stroke treatment emphasize the product's excellent tolerability, and a potential benefit in other conditions 1) before any treatment; 2) in those patients who have received fibrinolytic and glenzocimab simultaneously, and that these options are complementary development opportunities for the product.
The design of a new Phase 2/3 study evaluating glenzocimab in patients requiring thrombectomy is currently being drawn up by the Company.
GREEN and GALICE: ACTICOR is also continuing its collaboration with French stroke experts with 2 academically sponsored clinical studies in thrombectomized patients:
GREEN: Phase 2/3 clinical study in stroke treatment
GREEN (Glenzocimab for REperfusion in the setting of Endovascular therapy for brain infarctioN) is a randomized, double-blind, multicenter, placebo-controlled Phase 2/3 study of the efficacy and safety of glenzocimab as an adjunct to mechanical thrombectomy in acute ischemic stroke. The GREEN study is being conducted under the auspices of Assistance Publique - Hôpitaux de
As a reminder, the primary objective of this study is to evaluate the efficacy of glenzocimab in combination with endovascular thrombectomy (EVT) versus EVT alone, within the first 24 hours, on functional outcome at 90 days (mRS). Secondary objectives are to evaluate the impact of glenzocimab on overall survival, reperfusion, clinical improvement at 24 hours, symptomatic and asymptomatic intracerebral hemorrhage, serious adverse events (SAE), serious unexpected adverse events (SUSAR) and quality of life. The study will include 260 patients eligible for mechanical thrombectomy in 12 French neurovascular units and institutions of excellence. To date, over 85 patients have been included, and the results of the interim futility analysis are expected in Q4 2024.
GALICE: Phase 2/3 clinical study in stroke treatment
The GALICE study (Glenzocimab in Anterior stroke with Large Ischemic Core eligible for Endovascular therapy) is a randomized, double-blind, multicenter study that will include over 300 patients suffering from large ischemic stroke with proximal occlusion and eligible for mechanical thrombectomy. The objective of the study is to assess the efficacy and safety of glenzocimab versus placebo in improving neurological prognosis at 3 months.
The GALICE study is an academic study sponsored by the Adolphe de
The study received approval from the French regulatory authorities (ANSM and CPP) in
Other cardiovascular emergency indications
LIBERATE: Phase 2b clinical study in the treatment of myocardial infarction
The LIBERATE study, a randomized, double-blind Phase 2b trial, will enrol over 200 patients diagnosed with ST-elevation myocardial infarction (STEMI) and scheduled for percutaneous coronary intervention. The primary objective of the study is to evaluate both the safety and efficacy of glenzocimab at a dosage of 1000 mg compared to a placebo, specifically focusing on the reduction of myocardial infarct size at Day 90 post-treatment. The study is being conducted in partnership with the
About
The positive results of the phase 1b/2a study, ACTIMIS, published in
On
On
Glenzocimab is being evaluated in 2 other clinical trials initiated by academic teams:
- GREEN: a phase 2/3 study in the treatment of stroke in thrombectomized patients, with a futility analysis after inclusion of the first 78 patients (30% of patients) expected in Q4 2024;
- LIBERATE: a Phase 2b LIBERATE trial in the treatment of myocardial infarction, with final results expected in Q4 2025.
Contacts
Gilles AVENARD, MD CEO and Founder gilles.avenard@acticor-biotech.com Sophie BINAY, PhD General Manager and CSO Sophie.binay@acticor-biotech.com | NewCap Mathilde BOHIN Investor Relations acticor@newcap.eu T.: +33 (0)1 44 71 94 95 | NewCap Arthur ROUILLÉ Media Relations acticor@newcap.eu T.: +33 (0)1 44 71 00 15 |
Disclaimer
This press release contains forward-looking statements with respect to
1 Hospital program for clinical research
Attachment
- Acticor_PR_Point clinique_EN_vf-2
Source:
2024 GlobeNewswire, Inc., source