Acticor Biotech Announces the Enrollment of the First US Patient in its Phase 2/3 Study ACTISAVE for the Treatment of Stroke
26 September 2022 - 6:00PM
Business Wire
ACTICOR BIOTECH (ISIN: FR0014005OJ5 - ALACT) (Paris:ALACT), a
clinical-stage biotechnology company developing innovative drugs
for the treatment of cardiovascular emergencies, particularly
stroke, today announced the enrollment of the first patient in the
USA in its Phase 2/3 registration study ACTISAVE, which is
evaluating glenzocimab in patients with acute ischemic stroke.
This first US patient was enrolled at the CHI Memorial Stroke
and Neuroscience Center, Chattanooga, Tennessee, by Dr. Ruchir
A. Shah, MD, Neurologist who said: “I am very happy with this
first patient inclusion in the United States in ACTISAVE study.
Glenzocimab has significant potential for improvement in patients
with ischemic stroke, especially those undergoing mechanical
thrombectomy. We urgently need new drugs in this indication, and
glenzocimab presents an innovative and promising mechanism of
action on recanalization and on the downstream microcirculation.
Chattanooga CHI Memorial is a state-of-the-art stroke unit that
receives 1,400 stroke patients per year in unprecedented medical
conditions, with a large part given to research. "
ACTICOR had obtained an IND1 for this study from the U.S. Food
and Drug Administration (FDA) in November 2021 and had initiated
enrollment in Europe in the third quarter of 2021. To date, the
study has enrolled 130 patients.
The clinical trial is planned for 1,000 patients treated at
approximately 80 centers in the USA, Europe (France, Germany,
Belgium, Spain, Slovakia, Denmark, Czech Republic), Great Britain
and Israel. A first futility analysis is planned after the
inclusion of the first 200 patients to confirm the initial
hypotheses.
Dr. Yannick PLETAN, Chief Operating Officer, and Chief
Medical Officer of Acticor Biotech added: "The opening of the
first U.S. centers, in addition to those already active in Europe,
marks another important milestone for our ACTISAVE Phase 2/3 study.
The cumulative incidence of ischemic stroke in the USA, Europe,
Japan, and China will approach 4 million patients by 20262,
highlighting the urgent need for an effective treatment to address
this major public health problem with a strong societal and
economic impact.”
In July 2022, Acticor Biotech was granted Priority Medicines
(PRIME) status by the European Medicines Agency for glenzocimab in
the treatment of stroke, recognizing the potential clinical benefit
of glenzocimab and its relevance to the unmet medical need in this
disease. Because efficacy data were a secondary endpoint of the
Phase 1b/2a ACTIMIS study, glenzocimab was not eligible for
Breakthrough Therapy status despite significant data on mortality
and reduction of cerebral hemorrhage. Nevertheless, these data and
the inclusion of patients in the USA will allow Acticor Biotech to
apply for Fast Track status with the FDA in the coming weeks.
About ACTISAVE
ACTISAVE (NCT05070260) is a multinational, 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 standard
of care (thrombolysis +/- thrombectomy) for acute ischemic
stroke.
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.
Acticor Biotech is developing glenzocimab (ACT017), a humanized
monoclonal antibody (mAb) fragment directed against a novel target
of major interest, platelet glycoprotein VI (GPVI). Glenzocimab
inhibits platelet binding to the thrombus without affecting
physiological hemostasis, thereby limiting the bleeding risk,
particularly in the brain.
In May 2022, Acticor Biotech presented positive results from its
Phase 1b/2a study, ACTIMIS, at the ESOC, confirming the safety
profile and showing 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 (Karista, Go Capital, Newton Biocapital,
CMS Medical Venture Investment (HK) Limited, A&B (HK) Limited,
Mirae Asset Capital, Anaxago, Primer Capital, Mediolanum
farmaceutici 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
1 Investigational New Drug Application 2 Global data AIS
Epidemiology forecast to 2022
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version on businesswire.com: https://www.businesswire.com/news/home/20220926005624/en/
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
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