- Enrollment of the 200th patient in the ACTISAVE
study
- Initiation of patient enrollment in the GREEN Phase 2/3
study in stroke
- Update on the clinical evaluation of glenzocimab in stroke
and myocardial infarction
Regulatory News:
ACTICOR BIOTECH (ISIN: FR0014005OJ5 - ALACT) (Paris:ALACT), a
clinical-stage biotechnology company focused on the development of
innovative drugs for the treatment of cardiovascular emergencies,
in particular stroke, today provides an update on the progress of
its clinical programs with glenzocimab, its lead drug
candidate.
Gilles AVENARD, Chief Executive Officer and co-founder of
Acticor Biotech, said: "The beginning of this year is an
opportunity to review the progress of our clinical program
portfolio, which has reached crucial milestones since our IPO a
little over a year ago. Our clinical and regulatory development
teams have done a remarkable job, particularly in discussions with
the European regulatory authorities (EMA) for our Phase 2/3 study
ACTISAVE, in order to advance the preparation of a marketing
authorization application for glenzocimab in stroke. We have fully
met our patient enrollment goals in 2022 and are involving new
countries and hospitals in 2023. We are proud that the enrollment
of patients in the Phase 2/3 GREEN study, promoted by the AP-HP in
the framework of the RHU BOOSTER, has started. We look forward to
continuing the clinical development of glenzocimab in the treatment
of myocardial infarction in partnership with the University of
Birmingham (UK). We will keep up our efforts to provide a
therapeutic solution to this unmet medical need in cardiovascular
emergencies.”
1. ACTISAVE: Phase 2/3 clinical
study in stroke
Study design and regulatory discussions
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.
The study is being conducted in 7 European countries, UK, Israel,
and the USA.
The European Medicines Agency (EMA) approved the adaptive design
strategy and validated the choice of a dual primary endpoint: an
ordinal endpoint of the difference between the Modified Rankin
Scale (mRS)1 and a binary endpoint of the percentage of patients
with severe disability or death, i.e. an mRS score of 4-6. The
recognition of this pivotal study design supports a future
application for marketing authorization for glenzocimab in stroke
in Europe.
In the context of the "PRIME" status received in July 2022, a
program aimed at optimizing the development plan to speed up
patient access to the drug candidate, the company is continuing its
interactions with the EMA.
In the United States, discussions are underway with the American
regulatory agency (FDA) to set up a Type C meeting to validate the
design and statistical analysis of the study in support of a future
Biologic License Application (BLA) in the United States. An
amendment to the study protocol allowing the use of the two
recognized thrombolytic agents in stroke management, tenecteplase
(TNK) and alteplase, was submitted to the FDA in November 2022, and
is awaiting approval by the Ethics Review Board (IRB). Two patients
have been enrolled to date. This amendment should accelerate
enrollment, given the massive use of TNK in U.S. hospitals.
Number of patients recruited to date: 203 patients.
Next clinical step: an initial futility analysis is
planned when 100 patients will be enrolled with thrombolysis +
thrombectomy, treated and followed for 90 days to confirm the
safety of the study and ensure that the preliminary results are
consistent with the original trial assumptions. Results of this
futility study are expected in the 3rd quarter 2023.
2. GREEN: Phase 2/3 clinical
trial in stroke
Study design
GREEN (NCT05559398) 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 conducted under the auspices of
the Paris Public Hospitals (Assistance Publique – Hôpitaux de
Paris), and is part of the RHU BOOSTER, receiving financial support
from the French National Research Agency (Agence Nationale de la
Recherche) and the Government’s ‘Investments for the Future’
program (Programme Investissements d’Avenir).
The primary objective of this study is to evaluate the efficacy
of glenzocimab in combination with endovascular thrombectomy (EVT)
versus EVT alone on 90-day functional outcome (mRS). Secondary
objectives are to evaluate the impact of glenzocimab on overall
survival, reperfusion, clinical improvement at 24 hours,
symptomatic and asymptomatic intracerebral hemorrhage, serious
adverse events (SAEs), serious unexpected adverse events (SUSARs)
and quality of life. This study will include nearly 260 patients
eligible for mechanical thrombectomy in 11 French neurovascular
units and institutions of excellence.
Number of patients recruited to date: 1 patient.
Next clinical step: an interim analysis will be performed
after the first 78 patients are included and is expected end of
2023.
3) LIBERATE: Phase 2b clinical
trial in the treatment of myocardial infarction
Study design
LIBERATE (IRAS -1005400) is a randomized, double-blind, Phase 2b
study that will include more than 200 patients in the acute phase
of myocardial infarction to test the safety and efficacy of
glenzocimab 1000 mg versus placebo in reducing cardiac damage
remote from the infarction. This study is being conducted in
partnership with the University of Birmingham (UK), with expert
clinicians from the Institute of Cardiovascular Sciences and
University Hospitals Birmingham NHS Foundation Trust.
Current status of the study: file being submitted to the
UK regulatory authorities.
Next clinical step: Inclusion of the first patient
planned for the second quarter of 2023.
4. Other indications for cardiovascular emergencies
At this stage of development, Acticor Biotech has decided to
focus its efforts on the development of glenzocimab in stroke and
myocardial infarction with three ongoing studies (ACTISAVE, GREEN
and LIBERATE) and to postpone the launch of its Phase 2 study,
BREATHE in pulmonary embolism.
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
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.
17-point ordinal scale (categories 0 to 6) to measure the
degree of disability of a person who has had a stroke
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version on businesswire.com: https://www.businesswire.com/news/home/20230109005663/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 15
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