ACTIMIS Post-hoc Results on Imaging Stroke Data Using Artificial Intelligence Reinforces Glenzocimab Mode of Action in Stroke Patients
01 September 2023 - 2:38AM
Business Wire
Acticor Biotech, (ISIN: FR0014005OJ5 - ALACT), a clinical stage
biopharmaceutical company developing glenzocimab, an innovative
drug for the treatment of cardiovascular emergencies, announced
today the results of its collaboration with Brainomix Limited, to
further explore the imaging data using Artificial Intelligence (AI)
from its phase 1b/2a ACTIMIS study.
The ACTIMIS clinical trial evaluating glenzocimab in combination
with the reference treatment (thrombolysis with or without
thrombectomy) in patients presenting with Acute Ischemic Stroke
(AIS) has demonstrated a favorable safety profile of glenzocimab,
as well as a significant reduction in the number of intracerebral
hemorrhages and mortality in the group treated with
glenzocimab.
To explore the mode of action of glenzocimab in the reduction of
intracranial hemorrhage occurrence, a collaboration has been setup
with Brainomix, a UK company specialized in the creation of
AI-powered imaging biomarkers, to further analyze imaging stroke
results from ACTIMIS study.
In a post-hoc analysis of the ACTIMIS study results, ischemic
injury and hemorrhagic transformation volume measurements were
quantified using AI-enabled Brainomix software. This provided an
objective assessment of the evolution of the stroke brain injury
which was associated with clinical outcome. First results using
these biomarkers showed that patients treated with glenzocimab had
smaller stroke lesion volumes compared to placebo-recipients
(standard of care only), mainly due to a significant reduction in
hemorrhagic transformation volumes. The benefit of glenzocimab was
more pronounced in patients having undergone a mechanical
thrombectomy after an initial treatment by a thrombolytic
agent.
Yannick PLETAN, Chief Medical Officer and General Manager of
Acticor Biotech, explained: “We are delighted with this
collaboration with Brainomix, which enables us for the first time
to analyze in greater detail the brain images of patients in the
ACTIMIS study. Preliminary results seem to show that glenzocimab
not only reduces the occurrence of intracranial hemorrhages, but
also their volume, compared with placebo. These results support the
first analyses of the ACTIMIS study and will be submitted for
publication at upcoming international congresses.”
George HARSTON, Chief Medical Officer of Brainomix and
Consultant Stroke Physician said: "We are excited to have
partnered with Acticor Biotech to support this innovative analysis
of the ACTIMIS study using our AI-powered imaging biomarkers. The
Brainomix core lab analysis has helped elucidate the mechanism and
demonstrate efficacy of glenzocimab. It has shown that glenzocimab
reduced brain injury following thrombolysis in stroke, and
identified subgroups of patients who appear to benefit most."
About BRAINOMIX Limited
Brainomix specializes in the creation of AI-powered software
solutions to enable precision medicine for better treatment
decisions in stroke, lung fibrosis, and cancer. With origins as a
spin-out from the University of Oxford, Brainomix is an expanding
commercial-stage company that has innovated award-winning imaging
biomarkers and software solutions that are used in more than 30
countries worldwide and in multiple clinical trials for patient
selection and AI core lab analysis. Its first product, the
Brainomix 360 platform, provides clinicians with the most
comprehensive stroke imaging solution, driving faster treatment
times and improving functional independence for patients.
About ACTICOR BIOTECH
Acticor Biotech is a clinical stage biopharmaceutical company, a
spin-off from INSERM (the French National Institute of Health and
Medical Research), which is aiming to develop an innovative
treatment for cardiovascular emergencies, including ischemic
stroke.
The positive results from its Phase 1b/2a study, ACTIMIS,
confirmed the safety profile and showed a reduction in mortality
and intracerebral hemorrhage in the glenzocimab-treated group in
patients with stroke. The efficacy of glenzocimab is now being
evaluated in an international Phase 2/3 study, ACTISAVE, which will
include 1,000 patients. In July 2022, Acticor Biotech was granted
"PRIME" status by the European Medicines Agency (EMA) for
glenzocimab in the treatment of stroke. This designation will allow
the company to strengthen its interactions and obtain early
dialogues with regulatory authorities.
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).
Acticor Biotech is listed on Euronext Growth Paris since November
2021 (ISIN: FR0014005OJ5 – ALACT).
For more information, visit: www.acticor-biotech.com
Disclaimer
This press release contains certain forward-looking statements
concerning Acticor Biotech and its business. Such forward-looking
statements are based on assumptions that Acticor Biotech considers
to be reasonable. However, there can be no assurance that such
forward-looking statements will be verified, which statements are
subject to numerous risks, including the risks set forth in the
Document de référence registration document as approved by the
Autorité des marchés financiers under number R. 22-011 on 26 April
2022 and to the development of 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 not yet known to Acticor Biotech or not currently
considered material by Acticor Biotech. The occurrence of all or
part of such risks could cause actual results, financial
conditions, performance or achievements of Acticor Biotech to be
materially different from such forward-looking statements.
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ACTICOR BIOTECH Gilles AVENARD, MD CEO and Founder
gilles.avenard@acticor-biotech.com T. : +33 (0)6 76 23 38 13
Sophie BINAY, PhD General Manager and CSO
Sophie.binay@acticor-biotech.com T. : +33 (0)6 76 23 38
13
NewCap Mathilde BOHIN / Quentin MASSÉ 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
Brainomix Jeff WYRTZEN Chief Marketing & Business
Development Officer jwyrtzen@brainomix.com M.: +44 (0)7927 164210
T.: +44 (0)1865 582730
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