PARIS--(BUSINESS WIRE)--Regulatory News:

PARIS-（商业信息）-监管新闻：

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..

Acticor Biotech，（ISIN:FR0014005OJ5-ALACT）（巴黎：ALACT）是一家临床阶段生物制药公司，开发用于治疗心血管急症的创新药物glenzocimab，今天宣布其优化的急性缺血性卒中（AIS）发展计划，以注册glenzocimab在欧洲和美国。。

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..

ACTISAVE（NCT05070260）是一项国际2/3期研究，适应性，多中心，随机，双盲，安慰剂对照，平行组，评估单剂量格伦佐单抗联合参考治疗（溶栓有或没有机械血栓切除术）治疗急性缺血性中风。。

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).

在与欧洲（EMA）和美国（FDA）监管机构协商后，根据ACTISAVE的科学委员会的协议，Acticor Biotech决定将本研究的双重主要终点改为单一终点，即减少患者人数。因中风而死亡或患有严重残疾（90天时mRS评分4-6）。

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..

主要终点的这种修改，将研究规模缩小到400名患者，与最初计划的1000名患者相比，将使临床结果能够在2024年第二季度获得。。

Amending ACTISAVE study protocol should enable:

修改ACTISAVE研究协议应该能够：

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);

1） 更快地确认2022年2月在ACTIMIS研究中获得的疗效和安全性结果（最近由Brainomix研究证实）；

2) a simplification of the evaluation, replacing the interim futility analyses planned by a final analysis;

2） 简化评估，取代最终分析计划的临时无用分析；

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.

3） 有机会评估其他终点和几个亚群，最佳地支持最佳设计，并有可能确定那些应该从glenzocimab中获益最大的患者。

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..

迄今为止，部署在美国，欧洲，以色列和英国的ACTISAVE研究招募了380多名患者，其中35%接受了机械血栓切除术。ACTISAVE和ACTIMIS研究中包括的患者人群的比较表明，就纳入时的严重程度而言，ACTISAVE患者将在住院治疗中风的一般人群中更具代表性。。

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..

关于药物开发计划，Acticor在夏季收到了EMA和FDA的意见。当局证实了注册策略在生产过程验证和glenzocimab表征方面的相关性。已经提出了建议，并将在路线图中实施，而不会影响注册计划。。

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.

根据ACTISAVE 2/3期研究的结果和世界领先中风专家的建议，Acticor计划在2024年期间再次咨询EMA和FDA，以确认3期设计将支持欧洲和美国的注册。，预计不迟于2028年。

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.

Acticor Biotech首席执行官Gilles Avenard评论说：“我们对这一战略决策非常满意，这将使我们能够早在2024年中期获得临床结果。然后，我们将有两项独立研究显示我们的药物的疗效，我们将能够与FDA和EMA协商，确定第3阶段的设计，以便将这种有前景的药物注册用于治疗急性期中风。

This evolution of our clinical strategy also has the advantage of reducing our current costs and consequently our financing requirements for 2024”.

我们临床策略的这种发展还具有降低当前成本并因此降低2024年融资要求的优势。

Watch exclusive interview with Gilles Avenard

观看Gilles Avenard独家采访

https://youtu.be/HpMnBI_6Gio

https://youtu.be/HpMnBI_6Gio

About ACTICOR BIOTECH

关于ACTICOR生物技术

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是一家临床阶段生物制药公司，由INSERM（法国国家卫生与医学研究院）分拆而来，旨在为心血管紧急情况（包括缺血性中风）开发创新治疗方法。

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.

其1b/2a期研究ACTIMIS的阳性结果证实了安全性，并显示glenzocimab治疗组卒中患者的死亡率和脑出血减少。glenzocimab的疗效目前正在ACTISAVE国际2/3期研究中进行评估。

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..

2022年7月，Acticor Biotech被欧洲药品管理局（EMA）授予glenzocimab治疗中风的“主要”地位。这一指定将使公司能够加强其互动并获得与监管机构的早期对话。。

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)..

Acticor Biotech得到了欧洲和国际投资者（Mediolanum farmaceutici，Karista，Go Capital，Newton Biocapital，CMS Medical Venture Investment（HK）Limited，a＆B（HK）Limited，Anaxago和Armesa foundation）的支持。自2021年11月起，Acticor Biotech在Euronext Growth Paris上市（ISIN:FR0014005OJ5–ALACT）。。

For more information, visit: www.acticor-biotech.com

For more information, visit: www.acticor-biotech.com

Disclaimer

免责声明

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.

本新闻稿包含有关Acticor Biotech及其业务的某些前瞻性声明。这种前瞻性陈述是基于Acticor Biotech认为合理的假设。但是，不能保证这样的前瞻性陈述将得到验证，哪些陈述受到多种风险的影响，包括由r号下的AutoritédesMarchés融资人员批准的文件登记文件中规定的风险。

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.

2022年4月26日22-011以及Acticor Biotech运营的经济状况，金融市场和市场的发展。本新闻稿中包含的前瞻性声明还受到Acticor Biotech尚未知道或Acticor Biotech目前未视为材料的风险。

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..

全部或部分此类风险的发生可能导致Acticor Biotech的实际结果，财务状况，业绩或成就与此类前瞻性陈述大不相同。。