Regulatory News:
ACTICOR BIOTECH (FR0014005OJ5 - ALACT), a clinical stage
biopharmaceutical company developing glenzocimab, an innovative
drug for the treatment of cardiovascular emergencies, announces the
conclusions of the futility analysis of the phase 2/3 GREEN study
evaluating glenzocimab as an adjunct to mechanical thrombectomy in
acute ischemic stroke.
In the light of the information provided to the members of the
Independent Monitoring Committee (IMC), and in accordance with the
futility criteria defined in the protocol, the IMC recommends that
the GREEN study be discontinued.
In light of the Committee's recommendations, sponsor Assistance
Publique Hôpitaux de Paris (APHP), in agreement with Professor
Mikaël Mazighi, principal investigator of the study, has decided to
stop the GREEN study and halt enrolment. To date, 108 patients have
been included in the study, the futility analysis only covered the
first 78 patients, and all included patients will be analysed after
the 90-day protocol follow-up.
The GREEN study, sponsored by Assistance Publique - Hôpitaux de
Paris, is part of the RHU BOOSTER program, with financial support
from the Agence Nationale de la Recherche and the Programme
Investissements d'Avenir.
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 the first 24 hours of acute ischemic stroke.
About RHU BOOSTER
The RHU BOOSTER, Brain clOt persOnalized therapeutic Strategies
for sTroke Emergent Reperfusion, winner of the fourth call for
Hospital-University Research (RHU) projects in healthcare under the
future investment program, is led by Professor Mikael Mazighi,
Interventional Neuroradiology Department at Hôpital Fondation
Adolphe de Rothschild and Head of the Neurology Department at
Hôpital Lariboisière, has given itself 5 years (2019-2025) to
develop personalized medicine for ischemic stroke in emergency
situations. The RHU BOOSTER coordinated by the AP-HP brings
together a transdisciplinary consortium of 15 internationally
renowned partners with different areas of expertise: 5 experimental
research laboratories, 4 clinical research and imaging teams, 2
universities, 4 industrial partners
https://rhubooster.for.paris/
About GREEN
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.
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. Martin K�hrmann (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 also being evaluated in a Phase 2b LIBERATE
clinical trial initiated by academic teams 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).
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 Universal Registration Document as filed
with the Autorité des marchés financiers on July 9, 2024, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240725439354/en/
ACTICOR BIOTECH 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
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