Acticor Biotech updates its glenzocimab clinical
development plan for the treatment of cardiovascular
emergencies |
- 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)
Paris, France, June 3, 2024 – 6:00 CEST
- ACTICOR BIOTECH (FR0014005OJ5 - ALACT), a clinical stage
biopharmaceutical company developing glenzocimab, an innovative
drug for the treatment of cardiovascular emergencies, provides an
update on the clinical development of glenzocimab following the
release of results from its phase 2/3 ACTISAVE study.
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 Acticor Biotech in the treatment of ischemic
stroke
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, the UK and
the USA. The results of the 400-patient ACTISAVE trial were
presented at the European Congress (ESOC) in May 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 Paris, and is part of the RHU BOOSTER program, with
financial support from the Agence Nationale de la Recherche and the
Programme Investissements d'Avenir.
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 Rothschild Foundation Hospital and has received
public funding through a national PHRC in 2023. This new clinical
study is based on a long-standing collaboration between Acticor
Biotech and the Hôpital Fondation Adolphe de Rothschild.
The study received approval from the French
regulatory authorities (ANSM and CPP) in May 2024, and will take
place in 15 French university hospitals. The first patients are
expected to be enrolled in the 3rd quarter of 2024, for a 2-year
recruitment period.
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 University of
Birmingham (UK), and expert clinicians from the Institute of
Cardiovascular Sciences and University Hospitals Birmingham NHS
Foundation Trust. The two leading clinical research sites, Queen
Elizabeth Hospital Birmingham and Northern General Hospital
Sheffield, have been actively recruiting since January 2024. To
date, 16 patients have been recruited, with results expected in Q4
2025.
Acticor Biotech is also exploring other
cardiovascular emergency indications for glenzocimab. These
indications could include situations such as pulmonary embolism,
deep vein thrombosis, or other acute thrombotic events.
About ACTICOR BIOTECH
Acticor Biotech is a clinical-stage
biopharmaceutical company developing glenzocimab, an innovative
drug for the treatment of cardiovascular emergencies, particularly
ischemic stroke.
The positive results of the phase 1b/2a study,
ACTIMIS, published in January 2024 in the Lancet Neurology (link to
publication) confirmed the safety profile of glenzocimab and showed
a reduction in mortality and intracerebral hemorrhage in the
glenzocimab-treated group of stroke patients. A post-hoc analysis
of brain imaging at 0 and 24 hours using artificial intelligence
confirmed these results, showing a reduction in the number and
volume of intracerebral lesions in patients treated with
glenzocimab.
On April 25, 2024, the company announced the
initial results of the international phase 2/3 ACTISAVE study in
the treatment of acute ischemic stroke, which showed no efficacy of
glenzocimab on the primary endpoint, the proportion of patients
with severe disability or death (mRS 4-6) 90 days after stroke, nor
on the secondary endpoint, the proportion of patients returning to
life without disability (mRS 0-2).
On May 15, 2024, Prof. Mikael Köhrmann
(Principal Investigator of ACTISAVE) presented the main results of
the study at the opening session of the European Stroke
Organization Conference (ESOC), confirming the neutrality of the
study on the primary and secondary endpoints, and showing trends in
return to normal life (mRS 0-1), notably in sub-populations of
patients with complete recanalization after mechanical
thrombectomy.
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.
Acticor Biotech is supported by a panel of
European and international investors (Mediolanum farmaceutici,
Karista, Go Capital, Newton Biocapital, CMS Medical Venture
Investment (HK) Limited, A&B (HK) Limited, Anaxago, and the
Armesa Foundation) and has been listed on Euronext Growth Paris
since November 2021 (ISIN: FR0014005OJ5 - ALACT).
Contacts
ACTICOR
BIOTECHGilles AVENARD, MDCEO and Founder
gilles.avenard@acticor-biotech.com Sophie BINAY, PhDGeneral
Manager and CSO Sophie.binay@acticor-biotech.com |
NewCapMathilde BOHIN Investor Relations
acticor@newcap.euT.: +33 (0)1 44 71 94 95 |
NewCapArthur ROUILLÉMedia Relations
acticor@newcap.euT.: +33 (0)1 44 71 00 15 |
|
Disclaimer
This press release contains forward-looking
statements with respect to Acticor Biotech and its business.
Acticor Biotech believes that these forward-looking statements are
based on reasonable assumptions. However, no assurance can be given
that the expectations expressed in such forward-looking statements
will prove to have been correct, as they are subject to risks,
including those described in the Registration Document as approved
by the Autorité des marchés financiers under number R. 22-011 on
April 26, 2022, and to changes in economic conditions, financial
markets and the markets in which Acticor Biotech operates. The
forward-looking statements contained in this press release are also
subject to risks that are unknown to Acticor Biotech or that
Acticor Biotech does not currently consider material. The
occurrence of some or all of these risks could cause Acticor
Biotech's actual results, financial condition, performance or
achievements to differ materially from those expressed in the
forward-looking statements.
1 Hospital program for clinical research
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