Approval of study design by French ANSM and Ethics Committee Recruitment of 12 patients expected to start in Q4 2023 in 4 French centersFirst study results expected in mid-2024 Lyon (France) et Cambridge (MA, US), October 24, 2023, at 10:05 pm CEST – PHAXIAM Therapeutics (Nasdaq & Euronext: PHXM), a biopharmaceutical company developing innovative treatments for resistant bacterial infections, announces the approval of its phase 1 study clinical design in endocarditis infections caused by Staphylococcus aureus (S.

法国ANSM和伦理委员会批准研究设计招募12名患者预计将于2023年第4季度在4个法国中心开始招募第一项研究结果预计于2024年10月24日在法国里昂（法国）和剑桥（美国），2023年10月24日晚上10:05 CEST-PHAXIAM Therapeutics（纳斯达克和Euronext:PHXM），一家开发抗细菌感染创新疗法的生物制药公司，宣布批准金黄色葡萄球菌引起的心内膜炎感染1期临床研究设计（S）。

aureus) by the French National Agency for the Safety of Medicines and Health Products (ANSM) and the South-East II-Lyon Ethics Committee (Comité de Protection des Personnes - CPP). Endocarditis is an infection of the endocardium (inner lining of the heart) and valves, usually caused by bacteria. It can lead to heart failure, valve damage and stroke.

金黄色葡萄球菌）由法国国家药品和保健品安全局（ANSM）和东南II里昂伦理委员会（Comitéde Protection des Personnes-CPP）提供。心内膜炎是通常由细菌引起的心内膜（心脏内层）和瓣膜的感染。它可能导致心力衰竭，瓣膜损伤和中风。

It remains one of the most fatal heart diseases, with a death rate from 30 to 40%. The main cause of endocarditis infections, S. aureus, is responsible for around 30%1 of cases. Its treatment involves antibiotics, sometimes combined with surgery to repair damage to the heart valves. Despite advances in the prevention and treatment of other cardiovascular diseases, the incidence and mortality of endocarditis due to S.

它仍然是最致命的心脏病之一，死亡率从30%到40%。心内膜炎感染的主要原因是金黄色葡萄球菌，约占30%1的病例。其治疗涉及抗生素，有时与手术相结合以修复心脏瓣膜的损伤。尽管在预防和治疗其他心血管疾病方面取得了进展，但由于S引起的心内膜炎的发病率和死亡率。

aureus increased in recent years, requiring the development of innovative therapies to tackle antimicrobial resistance. The design of PHAXIAM's multicenter phase 1 study in this indication received the necessary approvals from the ANSM and Sud-Est II-Lyon Ethics committee. The trial plans to involve 12 patients requiring replacement of an infected heart valve.

金黄色葡萄球菌近年来增加，需要开发创新疗法来解决抗菌素耐药性问题。PHAXIAM在该适应症中进行的多中心1期研究的设计获得了ANSM和Sud Est II里昂伦理委员会的必要批准。该试验计划涉及12名需要更换感染心脏瓣膜的患者。

Recruited across 4 French hospitals (Henri Mondor in Créteil, Hôpital Bichat-Claude Bernard in Paris, University Hospital of Nantes and Universi.

在法国的4家医院（Créteil的Henri Mondor，巴黎的HôpitalBichat-Claude Bernard，南特大学医院和大学）招募。

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PR_PHAXIAM_Endocardite_EN_24-10-2023

PR_PHAXIAM_Endocarditis_EN_24-10-2023