- Data on specific subgroups pave the way for new
perspectives
- Continued commitment to conduct the phase 2/3 GREEN and
phase 2b LIBERATE studies has been confirmed.
Regulatory News:
ACTICOR BIOTECH (ISIN: FR0014005OJ5 – ALACT) (Paris:ALACT), a
clinical stage biopharmaceutical company developing glenzocimab, an
innovative drug for the treatment of cardiovascular emergencies,
including stroke, announces the presentation, on Wednesday, May 15,
2024 during the opening session of the 10th European Stroke
Organisation Conference (ESOC), of the phase 2/3 study results,
ACTISAVE, in the treatment of acute ischemic stroke.
On this occasion, Professor Martin K�hrmann, M.D., PhD.,
Coordinator Investigator of the ACTISAVE study, presented the main
results of the study during the opening session of the conference
"Official welcome & Large Clinical Trial": "ACTISAVE Clinical
Trial: Efficacy and Safety of Glenzocimab on Top of Thrombolysis
with or without Mechanical Thrombectomy." He also highlighted the
differences between the ACTIMIS and ACTISAVE studies in terms of
patient population.
Dr. Martin K�hrmann, M.D., PhD., Coordinator Investigator of
the ACTISAVE study, stated: "The analysis of the phase 2/3
ACTISAVE study in the treatment of acute ischemic stroke did not
demonstrate, in the overall population, the 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). However, a trend was observed in the
proportion of patients returning to normal life (mRS 0-1),
especially for patients with complete recanalization after
thrombectomy (eTICI score 3). These data encourage us to search for
patient subpopulations among whom an advantage of glenzocimab may
be demonstrated, as its favorable safety profile remains confirmed
in this study."
Gilles Avenard, Chief Executive Officer, developed: "We
are faced with results that challenge our initial expectations, but
the further analysis of the study data on certain subgroups is
promising. Glenzocimab has shown beneficial effects in certain
patient subgroups that warrant further exploration, allowing us to
consider continuing discussions with the pharmaceutical groups with
whom we are in contact. These data encourage us to refine and
potentially redefine the positioning of glenzocimab in the
treatment of strokes."
During this conference, in the "Hyperacute Management" session
on Wednesday, May 15th, Dr. Davide Carone from Brainomix Ltd will
also present the latest brain imaging analyses obtained in the
ACTIMIS study: "Patients randomized to Glenzocimab suffered less
hemorrhagic transformation with greater benefit in larger baseline
infarct core," reinforcing the potential of glenzocimab in certain
patient subpopulations, particularly those presenting larger
volumes of cerebral infarction at baseline.
Glenzocimab is also being evaluated in two other clinical
studies conducted by academic teams, which do not question their
work and confirm their confidence in the potential of the
product.
- Phase 2/3 GREEN study in the treatment of stroke in patients
undergoing mechanical thrombectomy with a futility analysis after
the inclusion of the first 78 patients (30% of patients) expected
in the fourth quarter of 2024;
- Phase 2b LIBERATE study in the treatment of myocardial
infarction with final results expected in the fourth quarter of
2025.
The company plans to actively continue discussions with
pharmaceutical partners to explore potential strategic
collaborations that could support future phases of glenzocimab's
development and clinical application.
As announced on April 25, 2024, during the release of the
ACTISAVE results, the company is able to fund its operations until
October 2024.
About ESOC
The European Stroke Organisation (ESO) is a pan-European society
of researchers and physicians specializing in strokes, national and
regional stroke societies, and non-professional organizations,
founded in December 2007. ESO is a non-governmental organization
composed of individual and organizational members. ESO serves as
the voice of stroke in Europe, harmonizing stroke care across
Europe and taking action to reduce the burden of stroke at regional
and global levels.
The 10th European Stroke Organisation Conference took place on
May 15th, 16th, and 17th, 2024, in Basel.
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.
Positive results from 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 haemorrhage 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 ACTISAVE trial (NCT05070260), an international phase 2/3 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) 90 days after stroke.
ACTISAVE (NCT05070260), an international, adaptive, multicenter,
randomized, double-blind, placebo-controlled, parallel-group Phase
2/3 study, evaluated the safety and efficacy of a single dose of
glenzocimab used in combination with the standard of care
(thrombolysis +/- thrombectomy) for acute ischemic stroke. The
study was deployed in the United States, Europe (8 countries),
Israel and the United Kingdom.
Acticor Biotech is currently investigating any influencing
factors that may have accounted for these results, which contradict
the findings of pharmacology studies and previous clinical
data.
Acticor Biotech is backed 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).
For further information, please visit:
https://www.acticor-biotech.com/
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version on businesswire.com: https://www.businesswire.com/news/home/20240515314114/en/
ACTICOR BIOTECH Gilles AVENARD, MD General Manager and
founder gilles.avenard@acticor-biotech.com
Sophie BINAY, PhD Chief Operating Officer and Scientific
Director 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
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