Acticor Biotech has Just and Timely Completed Patient Recruitment of Its Phase 2/3 Study in Stroke
November 07 2023 - 1:00AM
Business Wire
- 438 patients with stroke have been randomized in ACTISAVE
study evaluating glenzocimab, in the United-States, Europe, Israel
and United Kingdom
- Confirmation of clinical results communication for the
second quarter 2024
Regulatory News:
ACTICOR BIOTECH (FR0014005OJ5 - ALACT), a clinical stage
biopharmaceutical company developing glenzocimab, an innovative
drug for the treatment of cardiovascular emergencies, today
announces the timely completion of enrollment in the ACTISAVE Phase
2/3 clinical trial in patients with acute ischemic stroke
(AIS).
Gilles Avenard, General Manager of Acticor Biotech,
declares: « We are pleased with the completion of the enrollment of
our clinical study evaluating the efficacy of glenzocimab in 438
stroke patients exactly on schedule. We eagerly anticipate sharing
the outcomes of this world-class study in the second quarter of
2024. This achievement bolsters our commitment to delivering an
innovative drug for the treatment of cardiovascular emergencies,
that is strengthened, moving forward at every milestone of
development plan execution. »
Adeline Meilhoc, Head of Global Clinical Development of
Acticor Biotech, says: « We extend our heartfelt gratitude to
the patients and their families, as well as medical teams at about
70 clinical centers around the world for supporting this
extraordinary study. The pace of recruitment and the quality of the
data fill us with immense pride for our dedicated project teams,
who were able to stay the course despite the constraints associated
with conducting a trial in a medical emergency and the
international context. All have already expressed their willingness
to participate in the development of glenzocimab in future trials.
»
ACTISAVE (NCT05070260) is an international, adaptive,
multicenter, randomized, double-blind, placebo-controlled,
parallel-group Phase 2/3 study evaluating the safety and efficacy
of a single dose of glenzocimab used in combination with the
standard of care (thrombolysis +/- thrombectomy) for acute ischemic
stroke. Deployed in the United States, Europe, Israel, and United
Kingdom, ACTISAVE has enrolled 438 patients, of whom about 40% have
undergone mechanical thrombectomy.
As a reminder, following consultations with the European (EMA)
and American (FDA) regulatory agencies, and in agreement with
ACTISAVE Scientific Committee, Acticor Biotech decided in September
2023 to change the main endpoint of the study by retaining only one
single endpoint, namely the reduction in the number of patients who
died or suffered from severe disability as a result of AIS (mRS
score 4-6 at 90 days).
As previously announced, phase 2/3 clinical results are expected
in the second quarter of 2024.
Based on these results and the recommendations of international
experts in stroke, Acticor Biotech plans to consult again with the
EMA and the FDA in 2024 to confirm that the Phase 3 design will
support final registration in both Europe and the United States,
envisaged by 2028 at the latest.
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 of the phase 1b/2a study, ACTIMIS,
confirmed the safety profile of glenzocimab and showed a reduction
in mortality and intracerebral hemorrhage in the
glenzocimab-treated group of stroke patients. The efficacy of
glenzocimab is now being analyzed in an international Phase 2/3
study, ACTISAVE, with clinical results expected in Q2 2024.
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
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version on businesswire.com: https://www.businesswire.com/news/home/20231106363885/en/
ACTICOR BIOTECH Gilles AVENARD, MD Directeur Général et
fondateur gilles.avenard@acticor-biotech.com T. : +33 (0)6 76 23 38
13
Sophie BINAY, PhD Directeur Général Délégué et Directeur
Scientifique Sophie.binay@acticor-biotech.com T. : +33 (0)6 76 23
38 13
NewCap Mathilde BOHIN Relations Investisseurs
acticor@newcap.eu T. : +33 (0)1 44 71 94 95
NewCap Arthur ROUILLÉ Relations Médias acticor@newcap.eu
T. : +33 (0)1 44 71 00 15
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