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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
新聞稿
POSITIVE RECOMMENDATION OF THE DATA AND SAFETY MONITORING BOARD TO CONTINUE THE PHASE 2 STUDY EVALUATING ANTIVIRAL ACTIVITY OF MASITINIB IN COVID-19
數據和安全監測委員會繼續進行第二階段研究評估的積極建議馬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)今天宣佈，根據數據和安全監測委員會的建議，繼續進行第二階段研究，評估Masitinib在確診為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).
這項隨機(1：1)、雙盲、2期試驗(AB21002)在78名患者中進行，旨在評估Masitinib在有嚴重新冠肺炎風險的非住院患者和需要氧氣的住院患者(通過面罩或鼻管)中的抗病毒療效。
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.
分析是為了評估治療的安全性，並基於前50%的患者定向招募。Dsmb表示沒有安全問題，並建議不受限制地繼續這項研究。
This study is targeting the same population as registered antiviral treatments, namely Paxlovid® (Pfizer) and Molnupiravir® (Merck).
這項研究的目標人羣與註冊的抗病毒藥物相同，即帕昔洛韋®(輝瑞)和莫努皮拉韋®(默克)。
AB Science currently has two on-going phase 2 clinical studies in COVID-19:
AB Science目前在新冠肺炎有兩項正在進行的2期臨牀研究：
- 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，評估馬西替尼在有症狀的輕中度新冠肺炎患者中的抗病毒活性。
- AB20001研究，評估馬西替尼聯合異槲皮素治療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.
這兩項研究現在都得到了dsmb的積極推薦。
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).
關於AB Science
AB Science成立於2001年，是一家專門從事蛋白激酶抑制物(PKI)研究、開發和商業化的製藥公司。PKI是一類靶向蛋白質，其作用在細胞內的信號通路中至關重要。我們的計劃只針對有高度未得到滿足的醫療需求的疾病，這些疾病通常是致命的，短期存活或罕見或對以前的治療路線無效。
AB Science公司已經開發了一套專有的分子組合，該公司的先導化合物Masitinib已經註冊為獸藥，並在腫瘤學、神經系統疾病、炎症性疾病和病毒性疾病的人類藥物中進行開發。該公司總部設在法國巴黎，在巴黎泛歐交易所上市(股票代碼：AB)。
Further information is available on AB Science's website:
.
欲瞭解更多信息，請訪問AB Science的網站：
.
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.
前瞻性陳述-AB Science
本新聞稿包含前瞻性陳述。這些説法不是歷史事實。這些陳述包括預測和估計以及它們所依據的假設，以及基於有關財務結果、事件、運營、未來服務、產品開發及其潛在或未來表現的項目、目標、意圖和預期的陳述。
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.
這些前瞻性陳述通常可以通過“預期”、“預期”、“相信”、“打算”、“估計”或“計劃”以及其他類似術語來識別。雖然AB Science認為這些前瞻性陳述是合理的，但投資者需要注意的是，這些前瞻性陳述會受到許多風險和不確定性的影響，這些風險和不確定性很難預測，通常不在AB Science的控制範圍之內，這可能意味着結果和實際事件與前瞻性信息和陳述中表達、誘導或預期的內容大不相同。這些風險和不確定因素包括與本公司可能不成功的產品開發有關的不確定因素，或與主管當局授予的營銷授權有關的不確定因素，或更廣泛地説，可能影響AB Science開發的產品營銷能力的任何因素，以及AB Science發佈的公開文件中開發或確定的那些不確定因素。AB Science不承擔任何義務或承諾更新前瞻性信息和陳述，但須遵守適用的法規，特別是第223-1條及以下條款。《AMF總則》。
For additional information, please contact:
如需更多信息，請聯繫：
AB Science
Financial Communication & Media Relations
investors@ab-science.com
AB Science
財經傳播與媒體關係
郵箱：Investors@ab-Science.com
Attachment
依附
- CP Covid VENG VF
- CP Covid Veng VF
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moomoo是Moomoo Technologies Inc.公司提供的金融資訊和交易應用程式。
在美國，moomoo上的投資產品和服務由Moomoo Financial Inc.提供，一家受美國證券交易委員會（SEC）監管的持牌主體。 Moomoo Financial Inc.是金融業監管局（FINRA）和證券投資者保護公司（SIPC）的成員。
在新加坡，moomoo上的投資產品和服務是通過Moomoo Financial Singapore Pte. Ltd.提供，該公司受新加坡金融管理局（MAS）監管(牌照號碼︰CMS101000) ，持有資本市場服務牌照 (CMS) ，持有財務顧問豁免（Exempt Financial Adviser）資質。本內容未經新加坡金融管理局的審查。
在澳大利亞，moomoo上的金融產品和服務是通過Futu Securities (Australia) Ltd提供，該公司是受澳大利亞證券和投資委員會(ASIC)監管的澳大利亞金融服務許可機構（AFSL No. 224663）。請閱讀並理解我們的《金融服務指南》、《條款與條件》、《隱私政策》和其他披露文件，這些文件可在我們的網站 https://www.moomoo.com/au中獲取。
在加拿大，透過moomoo應用程式提供的僅限訂單執行的券商服務由Moomoo Financial Canada Inc.提供，並受加拿大投資監管機構（CIRO）監管。
在馬來西亞，moomoo上的投資產品和服務是透過Moomoo Securities Malaysia Sdn. Bhd. 提供，該公司受馬來西亞證券監督委員會（SC）監管(牌照號碼︰eCMSL/A0397/2024) ，持有資本市場服務牌照 (CMSL) 。本內容未經馬來西亞證券監督委員會的審查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd.，Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc和Moomoo Securities Malaysia Sdn. Bhd., 是關聯公司。
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