- Approval of ACTISAVE design by the EMA to support a
potential future marketing authorization application (MAA) for
glenzocimab in Stroke
- Validation du choix d’un double critère d’évaluation
principal :
- Échelle de Rankin modifiée (mRS)1 - Échec (versus
succès) défini par un handicap grave ou le décès, soit un score mRS
4-6 versus mRS 0-3
Regulatory News:
Acticor Biotech, (ISIN: FR0014005OJ5 - ALACT) (Paris:ALACT), a
clinical stage biopharmaceutical company developing glenzocimab, an
innovative drug for the treatment of cardiovascular emergencies,
has discussed with the European Medicines Agency (EMA) the design
of its pivotal Phase II/III study to support a potential future
marketing authorization application (MAA) for its first-in-class
drug, glenzocimab.
The discussion meeting took place remotely in October 2022, and
Acticor Biotech provided a list of questions concerning the
non-clinical development and the study design of the ACTISAVE
study.
The final advice given by the Committee for Medicinal Product
for Human use (CHMP) based on the questions and supporting
discussion was very positive. The Agency endorsed the strategy of
an adaptive design and validated the choice of two dual primary
endpoints: the modified Rankin Scale as an ordinal scale in 7
categories from 0 to 6 and the binary endpoint defined as severe
disability or death, i.e., mRS 4-6 (versus mRS 0-3).
Other key features of the study design were also endorsed, such
as the two futility interim analyses proposed with their go/no go
rules, the prespecified analysis in the promising subgroup of
patients with thrombectomy and the adaptive reassessment of the
sample size at the second futility analysis. Although CHMP
recommendations were issued to further detail some analyses, the
statistical methodology was therefore endorsed on its general
principles.
In addition, the CHMP agreed that reproductive and developmental
toxicity studies are not requested to support a future MAA,
considering glenzocimab profile and safety results on previous
nonclinical studies.
As reminder, the positive results of the ACTIMIS phase 1b/2a
clinical trial evaluating glenzocimab in combination with the
reference treatment (thrombolysis with or without thrombectomy) in
patients presenting with acute ischemic stroke (AIS) demonstrated
glenzocimab very favorable safety profile by meeting the main
criterion of the trial as well as by showing a significant
reduction in the number of intracerebral hemorrhages and mortality
in the group treated with glenzocimab.
Glenzocimab was granted PRIME designation in July 2022, and
frequent interactions with the EMA will be planned under the PRIME
scheme to optimize the development plan and facilitate quicker
access for patients of the drug candidate. To date, the ACTISAVE
study has enrolled more than 180 patients. A first futility
analysis is planned after 200-300 patients will have been
recruited, treated, and monitored for 90 days to confirm safety and
ascertain that preliminary results are aligned with the initial
trial assumptions.
Dr. Yannick PLETAN, Chief Medical Officer of Acticor
Biotech comments: “It is presumably the first time that such an
adaptive protocol is developed and regulatorily endorsed in acute
ischemic stroke. It testifies to the urgent need to develop
innovative designs to support the rapid advent of novel solutions
to cure that terrible condition. We’re very proud that glenzocimab
can benefit from this recognition.”
Pr Jean-Marie GROUIN, Expert Statistician, added: “The
adaptive design proposed in ACTISAVE study optimizes the chances of
proving glenzocimab efficacy for the benefit of patients who suffer
from this dramatic condition.”
Laurie Jullien, Head of Regulatory Affairs of Acticor
Biotech concluded: “This new interaction with the EMA paves the
way of a reinforced dialogue to build an efficient development up
to the marketing authorization application. We look forward to
having additional consultations in 2023 under the PRIME scheme and
discuss further our proposed registration strategy. “
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
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.
1 an ordinal scale in 7 categories from 0 to 6 to measure
the degree of disability of a stroke patient
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version on businesswire.com: https://www.businesswire.com/news/home/20221205005453/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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