ACTICOR BIOTECH: Topline Results of ACTISAVE Phase 2/3 Study in Stroke Treatment
April 25 2024 - 2:00AM
Business Wire
- Analysis of the primary and secondary endpoints of the phase
2/3 ACTISAVE study showed no improved efficacy with
glenzocimab
- Key results from this study will be presented at ESOC on May
15, 2024, at 11:00 am
Regulatory News:
ACTICOR BIOTECH (FR0014005OJ5 - ALACT) (Paris:ALACT), a
clinical-stage biotechnology company focused on the development of
glenzocimab, an innovative drug for the treatment of cardiovascular
emergencies, today announced the first results of its ACTISAVE
phase 2/3 study in the treatment of acute ischemic stroke.
Analysis of the first results shows no evidence of efficacy for
either the primary endpoint, the proportion of patients with severe
disability or death (mRS 4-6) at 90 days after the stroke, or for
the secondary endpoint, the proportion of patients with no
disability (mRS 0-2) at 90 days.
As a reminder, ACTISAVE (NCT05070260), an international,
adaptive, multicenter, randomized, double-blind,
placebo-controlled, parallel-group Phase 2/3 study, evaluated the
safety and efficacy of a single dose of glenzocimab used in
combination with the standard of care (thrombolysis +/-
thrombectomy) for acute ischemic stroke. The study was deployed in
the United States, Europe (8 countries), Israel and the United
Kingdom.
Yannick PLETAN, General Manager & Chief Medical Officer,
comments: "These results obtained with glenzocimab in
combination with the reference stroke treatment are extremely
disappointing and in contradiction with the results of the previous
phase 1b/2a ACTIMIS study and pharmacological studies. The ACTISAVE
study included 438 patients, of whom 421 were treated, including
211 in the glenzocimab arm. Treatment was systematically combined
with thrombolysis, and for just over 30% of patients with
mechanical thrombectomy. The study population proved to be
significantly less severe than that of ACTIMIS, with a very high
percentage of patients returning to near-normal life. This negative
result for Acticor is also negative for the medical community
awaiting new treatments. It contradicts the results of previous
pharmacological studies and clinical data. Main quality aspects of
the study were analysed and found to be compliant. ACTICOR is
currently investigating any influencing factors that may have
accounted for these results. We're also assessing the potential
impact on the 2 other clinical studies currently underway: GREEN in
stroke patients undergoing mechanical thrombectomy and LIBERATE in
myocardial infarction (STEMI). We would like to thank all the
patients who took part in the ACTISAVE study, as well as their
doctors and hospital teams. The full data will be presented on May
15 at a plenary session of the European Stroke Organization
Conference (ESOC) by Professor Martin K�hrmann, coordinating
investigator."
Gilles AVENARD, Chief Executive Officer explains: "We
will continue to investigate these results to better understand and
evaluate consequences of this study with the investigators, the US
and European regulatory agencies and our Board of Directors, to
determine what further action should be taken. As previously
announced, the Company is able to finance its operations until
October 2024."
The ESOC oral presentation (abstract n°357) is entitled
“ACTISAVE Clinical Trial: Efficacy and Safety of Glenzocimab on Top
of Thrombolysis with or without Mechanical Thrombectomy” and will
be held on May 15, 2024, at 11:00 am.
Glenzocimab is currently evaluated in two other clinical studies
sponsored by academic teams:
- A Phase 2/3 GREEN study in stroke patients undergoing
mechanical thrombectomy, with a futility analysis following the
inclusion of the first 78 patients (30% of patients) expected in Q4
2024.
- A phase 2b LIBERATE study in the treatment of myocardial
infarction, with final results expected in Q4 2025.
As reminder, the Company will publish its 2023 Full-Year Results
and the URD on April 30, 2024, the General Meeting will take place
on June 21, 2024.
About ACTICOR BIOTECH
Acticor Biotech is a clinical-stage biopharmaceutical company
developing glenzocimab, an innovative drug for the treatment of
cardiovascular emergencies, particularly ischemic stroke.
Positive results from the phase 1b/2a study, ACTIMIS, published
in January 2024 in the Lancet Neurology (link to publication)
confirmed the safety profile of glenzocimab and showed a reduction
in mortality and intracerebral haemorrhage in the
glenzocimab-treated group of stroke patients. These results were
confirmed by a post-hoc analysis of brain imaging at 0 and 24 hours
using artificial intelligence (Brainomix, UK). This independent
analysis confirmed the reduction in the number and volume of
intracerebral lesions in patients treated with glenzocimab.
In July 2022, Acticor Biotech obtained "PRIME" status from the
European Medicines Agency (EMA) for glenzocimab in the treatment of
stroke. This designation enables the company to strengthen its
interactions and obtain early dialogues with regulatory
authorities.
Acticor Biotech is backed 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)
and has been listed on Euronext Growth Paris since November 2021
(ISIN: FR0014005OJ5 - ALACT).
For further information, please visit:
https://www.acticor-biotech.com/
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version on businesswire.com: https://www.businesswire.com/news/home/20240424916910/en/
ACTICOR BIOTECH Gilles AVENARD, MD General Manager and
founder gilles.avenard@acticor-biotech.com T.: +33 (0)6 76 23 38
13
Sophie BINAY, PhD Chief Operating Officer and Scientific
Director 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
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