新型药物研发商Seres Therapeutics口服活体生物治疗药SER医药_健康_365医药针灸按摩医药_健康_365医药中医中药医药_健康

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新型药物研发商Seres Therapeutics口服活体生物治疗药SER-155获得突破性疗法认定 Seres Therapeutics Receives Breakthrough Therapy Designation for SER-155 PHARMA FOCUS ASIA 等信源发布 2024-12-10 14:51 

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Seres Therapeutics has announced the regulatory approval of SER-155, a treatment aimed at reducing bloodstream infections (BSIs) in adults undergoing allogeneic haematopoietic stem cell transplant (allo-HSCT) as part of their therapy for haematological malignancies.SER-155 is an investigational oral live biotherapeutic designed to target gastrointestinal (GI) pathogens, enhance epithelial barrier function, and promote immune tolerance.

Seres Therapeutics已宣布监管部门批准SER-155，该疗法旨在减少接受异基因造血干细胞移植（allo-HSCT）的成年人的血流感染（BSI），作为其血液恶性肿瘤治疗的一部分。

It prevents bacterial bloodstream infections, antimicrobial resistance (AMR)-related complications, and other adverse clinical outcomes associated with pathogens in allo-HSCT patients.The efficacy of SER-155 has been assessed in a Phase 1b placebo-controlled trial involving patients undergoing allo-HSCT.

它可以预防异基因造血干细胞移植患者的细菌性血流感染、抗菌素耐药性（AMR）相关并发症以及其他与病原体相关的不良临床结果。SER-155的疗效已在1b期安慰剂对照试验中进行了评估，该试验涉及接受allo-HSCT的患者。

The study revealed significant reductions in BSIs, systemic antibiotic use, and the incidence of febrile neutropenia.The treatment has been granted breakthrough therapy designation for its role in reducing BSIs and fast track designation for its potential to lower the risk of infections and graft-versus-host disease (GvHD) in HSCT patients.BSIs are a frequent, severe, and potentially fatal complication in allo-HSCT patients.

该研究显示BSI，全身抗生素使用和发热性中性粒细胞减少症的发生率显着降低。该疗法因其在减少BSI方面的作用而被授予突破性治疗称号，并因其降低HSCT患者感染和移植物抗宿主病（GvHD）风险的潜力而被授予快速通道称号。BSI是allo-HSCT患者常见，严重且可能致命的并发症。

Current clinical practise involves aggressive management with broad-spectrum antibiotics for those experiencing BSIs or febrile neutropenia, as infections are among the leading causes of mortality in the first 100 days post-transplant. However, while antibiotic prophylaxis is commonly used, it does not address the root cause of these infections, a gap SER-155 aims to fill.Beyond allo-HSCT, BSIs are a serious concern for various medically vulnerable groups, including patients undergoing autologous-HSCT, cancer patients with neutropenia, CAR-T therapy recipients, individuals with chronic liver disease, solid organ trans.

目前的临床实践涉及对患有BSI或发热性中性粒细胞减少症的患者积极使用广谱抗生素，因为感染是移植后前100天死亡的主要原因之一。然而，虽然抗生素预防是常用的，但它并不能解决这些感染的根本原因，SER-155旨在填补这一空白。除allo-HSCT外，BSI是各种医学弱势群体的严重担忧，包括接受自体HSCT的患者，中性粒细胞减少的癌症患者，CAR-T治疗受者，慢性肝病患者，实体器官移植患者。

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