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AB Science - Positive Recommendation of the Data and Safety Monitoring Board to Continue the Phase 2 Study Evaluating the Antiviral Activity of Masitinib in Covid-19
AB Science - Positive Recommendation of the Data and Safety Monitoring Board to Continue the Phase 2 Study Evaluating the Antiviral Activity of Masitinib in Covid-19
PRESS RELEASE
POSITIVE RECOMMENDATION OF THE DATA AND SAFETY MONITORING BOARD TO CONTINUE THE PHASE 2 STUDY EVALUATING ANTIVIRAL ACTIVITY OF MASITINIB IN COVID-19
Paris, 14 September 2022, 6.15pm CET
AB Science SA (Euronext - FR0010557264 - AB) today announced continuation of the Phase 2 study evaluating the antiviral activity of masitinib in patients who have a confirmed diagnosis of COVID-19, following the recommendation of the Data and Safety Monitoring Board (DSMB).
This randomized (1:1), double-blind, phase 2 study (AB21002) in 78 patients, is designed to evaluate the anti-viral efficacy of masitinib in non hospitalized patients who are at risk of developing severe COVID-19 and in hospitalized patients with need of oxygen (via face mask or nasal cannula).
The analysis was to assess the safety of the treatment and was based on the first 50% of the patient targeted recruitment. The DSMB indicated that there was no safety concern and recommended continuation of the study without restrictions.
This study is targeting the same population as registered antiviral treatments, namely Paxlovid® (Pfizer) and Molnupiravir® (Merck).
AB Science currently has two on-going phase 2 clinical studies in COVID-19:
- Study AB21002, evaluating the antiviral activity of masitinib in patients with symptomatic mild to moderate COVID-19.
- Study AB20001, evaluating the safety and efficacy of masitinib plus isoquercetin in hospitalized patients with moderate or severe COVID-19.
Both studies have now received positive recommendation from the DSMB.
About AB Science
Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment.
AB Science has developed a proprietary portfolio of molecules and the Company's lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).
Further information is available on AB Science's website:
.
Forward-looking Statements - AB Science
This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance.
These forward-looking statements can often be identified by the words "expect", "anticipate", "believe", "intend", "estimate" or "plan" as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations.
For additional information, please contact:
AB Science
Financial Communication & Media Relations
investors@ab-science.com
Attachment
- CP Covid VENG VF
PRESS RELEASE
新闻稿
POSITIVE RECOMMENDATION OF THE DATA AND SAFETY MONITORING BOARD TO CONTINUE THE PHASE 2 STUDY EVALUATING ANTIVIRAL ACTIVITY OF MASITINIB IN COVID-19
数据和安全监测委员会继续进行第二阶段研究评估的积极建议马西替尼的抗病毒活性在新冠肺炎
Paris, 14 September 2022, 6.15pm CET
巴黎, 2022年9月14日, 6.15pm塞特
AB Science SA (Euronext - FR0010557264 - AB) today announced continuation of the Phase 2 study evaluating the antiviral activity of masitinib in patients who have a confirmed diagnosis of COVID-19, following the recommendation of the Data and Safety Monitoring Board (DSMB).
AB Science SA(Euronext-FR0010557264-AB)今天宣布，根据数据和安全监测委员会的建议，继续进行第二阶段研究，评估Masitinib在确诊为新冠肺炎患者中的抗病毒活性。
This randomized (1:1), double-blind, phase 2 study (AB21002) in 78 patients, is designed to evaluate the anti-viral efficacy of masitinib in non hospitalized patients who are at risk of developing severe COVID-19 and in hospitalized patients with need of oxygen (via face mask or nasal cannula).
这项随机(1：1)、双盲、2期试验(AB21002)在78名患者中进行，旨在评估Masitinib在有严重新冠肺炎风险的非住院患者和需要氧气的住院患者(通过面罩或鼻管)中的抗病毒疗效。
The analysis was to assess the safety of the treatment and was based on the first 50% of the patient targeted recruitment. The DSMB indicated that there was no safety concern and recommended continuation of the study without restrictions.
分析是为了评估治疗的安全性，并基于前50%的患者定向招募。Dsmb表示没有安全问题，并建议不受限制地继续这项研究。
This study is targeting the same population as registered antiviral treatments, namely Paxlovid® (Pfizer) and Molnupiravir® (Merck).
这项研究的目标人群与注册的抗病毒药物相同，即帕昔洛韦®(辉瑞)和莫努皮拉韦®(默克)。
AB Science currently has two on-going phase 2 clinical studies in COVID-19:
AB Science目前在新冠肺炎有两项正在进行的2期临床研究：
- Study AB21002, evaluating the antiviral activity of masitinib in patients with symptomatic mild to moderate COVID-19.
- Study AB20001, evaluating the safety and efficacy of masitinib plus isoquercetin in hospitalized patients with moderate or severe COVID-19.
- 研究AB21002，评估马西替尼在有症状的轻中度新冠肺炎患者中的抗病毒活性。
- AB20001研究，评估马西替尼联合异槲皮素治疗中重度新冠肺炎住院患者的安全性和有效性。
Both studies have now received positive recommendation from the DSMB.
这两项研究现在都得到了dsmb的积极推荐。
About AB Science
Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment.
AB Science has developed a proprietary portfolio of molecules and the Company's lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).
关于AB Science
AB Science成立于2001年，是一家专门从事蛋白激酶抑制物(PKI)研究、开发和商业化的制药公司。PKI是一类靶向蛋白质，其作用在细胞内的信号通路中至关重要。我们的计划只针对有高度未得到满足的医疗需求的疾病，这些疾病通常是致命的，短期存活或罕见或对以前的治疗路线无效。
AB Science公司已经开发了一套专有的分子组合，该公司的先导化合物Masitinib已经注册为兽药，并在肿瘤学、神经系统疾病、炎症性疾病和病毒性疾病的人类药物中进行开发。该公司总部设在法国巴黎，在巴黎泛欧交易所上市(股票代码：AB)。
Further information is available on AB Science's website:
.
欲了解更多信息，请访问AB Science的网站：
.
Forward-looking Statements - AB Science
This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance.
前瞻性陈述-AB Science
本新闻稿包含前瞻性陈述。这些说法不是历史事实。这些陈述包括预测和估计以及它们所依据的假设，以及基于有关财务结果、事件、运营、未来服务、产品开发及其潜在或未来表现的项目、目标、意图和预期的陈述。
These forward-looking statements can often be identified by the words "expect", "anticipate", "believe", "intend", "estimate" or "plan" as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations.
这些前瞻性陈述通常可以通过“预期”、“预期”、“相信”、“打算”、“估计”或“计划”以及其他类似术语来识别。虽然AB Science认为这些前瞻性陈述是合理的，但投资者需要注意的是，这些前瞻性陈述会受到许多风险和不确定性的影响，这些风险和不确定性很难预测，通常不在AB Science的控制范围之内，这可能意味着结果和实际事件与前瞻性信息和陈述中表达、诱导或预期的内容大不相同。这些风险和不确定因素包括与本公司可能不成功的产品开发有关的不确定因素，或与主管当局授予的营销授权有关的不确定因素，或更广泛地说，可能影响AB Science开发的产品营销能力的任何因素，以及AB Science发布的公开文件中开发或确定的那些不确定因素。AB Science不承担任何义务或承诺更新前瞻性信息和陈述，但须遵守适用的法规，特别是第223-1条及以下条款。《AMF总则》。
For additional information, please contact:
如需更多信息，请联系：
AB Science
Financial Communication & Media Relations
investors@ab-science.com
AB Science
财经传播与媒体关系
邮箱：Investors@ab-Science.com
Attachment
依附
- CP Covid VENG VF
- CP Covid Veng VF
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