- Clinical results from ACTISAVE phase 2/3 study now expected
in the second quarter of 2024
- Optimised development plan to register glenzocimab
in Europe and the United States projected no later than
2028
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,
announced today its optimised development plan for Acute Ischemic
Stroke (AIS) to register glenzocimab in Europe and the United
States.
ACTISAVE (NCT05070260) is an international phase 2/3 study,
adaptive, multicentre, randomised, double-blind,
placebo-controlled, parallel-group evaluating the safety and
efficacy of a single dose of glenzocimab used in combination with
the reference treatment (thrombolysis with or without mechanical
thrombectomy) for acute ischaemic stroke.
After consultation with the European (EMA) and US (FDA)
regulatory agencies, in agreement with ACTISAVE's scientific
committee, Acticor Biotech has decided to change the dual primary
endpoint of this study to a single endpoint, namely the reduction
in the number of patients who died or suffered from severe
disability as a result of the stroke (mRS score 4-6 at 90 days).
This modification of the primary endpoint, reducing the size of the
study to 400 patients compared to 1,000 initially planned, will
enable clinical results to be obtained as early as in the second
quarter of 2024.
Amending ACTISAVE study protocol should enable:
1) a quicker confirmation of the efficacy and safety results
obtained in February 2022 in the ACTIMIS study (and recently
confirmed by the Brainomix study); 2) a simplification of the
evaluation, replacing the interim futility analyses planned by a
final analysis; 3) an opportunity to evaluate additional endpoints
and several subpopulations, optimally supporting the best possible
design and making it possible to identify those patients who should
draw the best benefit from glenzocimab.
To date, the ACTISAVE study deployed in the United States,
Europe, Israel, and the United Kingdom, has recruited more than 380
patients, 35% of whom have undergone a mechanical thrombectomy.
Comparison of the patient populations included in ACTISAVE and
ACTIMIS studies suggests that ACTISAVE patients will be more
representative, in terms of severity at inclusion, of the general
population of patients treated in hospital for a stroke.
Regarding the pharmaceutical development plan, Acticor received
the opinion from EMA and FDA during the summer. The authorities
confirmed the relevance of the registration strategy in terms of
production process validation and glenzocimab characterization.
Recommendations have been proposed and will be implemented in the
roadmap, without impacting the registration plan.
Based on the results of the ACTISAVE phase 2/3 study and on
recommendations from world leading stroke experts, Acticor plans to
consult the EMA and FDA again during 2024 to confirm that the phase
3 design will support registration in both Europe and the United
States, projected no later than 2028.
Gilles Avenard, Chief Executive Officer of Acticor
Biotech, commented: "We are very pleased with this strategic
decision, which will enable us to obtain clinical results as early
as mid-2024. We will then have two independent studies showing the
efficacy of our drug and we will be able to define, in consultation
with the FDA and the EMA, the design of phase 3 for the
registration of this promising drug in the treatment of the acute
phase of stroke. This evolution of our clinical strategy also has
the advantage of reducing our current costs and consequently our
financing requirements for 2024”
Watch exclusive interview with Gilles
Avenard https://youtu.be/HpMnBI_6Gio
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. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230914727576/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 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
Acticor Biotech (EU:ALACT)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
Acticor Biotech (EU:ALACT)
Gráfica de Acción Histórica
De May 2023 a May 2024