Clarithromycin

SUZHOU, China, Nov 18, 2024 /PRNewswire/ -- TenNor Therapeutics, a clinical-stage company dedicated to developing novel therapies to address unmet needs in infectious diseases, announced today the successful completion of a phase III clinical trial of rifasutenizol (TNP-2198) for the treatment of Helicobacter pylori (H. pylori) infection. The study met its primary endpoints, showing multiple advantages of rifasutenizol regimen compared with bismuth-containing quadruple therapy (BQT), the current standard of care. The completed study is a multicenter, randomized, double-blind, controlled phase III clinical trial to evaluate the efficacy and safety of TNP-2198 in combination with amoxicillin and rabeprazole for the treatment of H. pylori infection in treatment-naive patients. The study was conducted in 40 hospitals in China. A total of 700 treatment-naive patients with H. pylori infection confirmed by a positive carbon-13 urea breath test (C-13 UBT) and histological examination were randomly assigned in a 1:1 ratio to receive rifasutenizol triple therapy (rifasutenizol 400 mg, amoxicillin 1 g and rabeprazole 20 mg) or BQT (bismuth potassium citrate 240 mg, clarithromycin 500 mg, amoxicillin 1 g and rabeprazole 20 mg) treatment, twice a day for 14 days. The efficacy endpoint was the C-13 UBT test result 4 to 6 weeks after the end of treatment. Patient compliance was high in the study with a low dropout rate of 3%. H. pylori was successfully cultured in 87% patients. There were no significant differences in demographics or baseline antibiotic resistance characteristics between the two treatment groups that could affect the study outcomes. Resistance rates to clarithromycin, metronidazole, levofloxacin and amoxicillin among H. pylori clinical isolates from this study were 41%, 68%, 35% and 8% respectively, which are consistent with data reported recently by other studies, indicating antibiotic resistance to H. pylori is a serious problem in China. All clinical isolates from the study were susceptible to rifasutenizol. Rifasutenizol triple therapy achieved >90% eradication rate in the modified intention-to-treat (mITT) population, higher than BQT control (92.0% vs. 87.9%, difference 4.1%, non-inferiority test p<0.0001, superiority test p= 0.0338). The rifasutenizol regimen also achieved a higher eradication rate than BQT in the per protocol (PP) population (93.7% vs. 90.3%, difference 3.4%, non-inferiority test p<0.0001, superiority test p=0.0563). In patients infected with H. pylori resistant to any of the current antibiotics, rifasutenizol triple therapy also achieved a higher eradication rate than BQT (90.9% vs. 87.2%, difference 3.7%, non-inferiority test p<0.0001), indicating rifasutenizol regimen is highly effective in patients with antibiotic-resistant H. pylori infections. Rifasutenizol regimen showed better safety and tolerability profile than BQT. The treatment-emergent adverse events (TEAEs), investigational drug related TEAEs, TEAEs with grade 3 or above are all lower in the rifasutenizol arm. Most TEAEs were Grade 1 and no investigational drug related serious adverse events (SAEs) reported. Rifasutenizol is a novel multi-targeting drug candidate with a synergistic mechanism of action against anaerobic and microaerophile bacteria. It has potential to become the first new drug developed specifically for H. pylori infection in more than 30 years. Rifasutenizol could play an important role in supporting the large-scale test-and-treatment strategy to prevent gastric cancers in populations with high gastric cancer risk, as the rifasutenizol regimen does not require drug sensitivity test and can be seamlessly integrated with the UBT testing. TenNor completed 7 phase I-III clinical trials in China and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration (FDA). About TenNor Therapeutics TenNor Therapeutics is a clinical-stage company specialized in the discovery and development of differentiated new drug products for diseases associated with bacterial infection and metabolism. TenNor possesses a unique multi-targeting drug conjugate technology and a strong new drug development portfolio with global IP protection. Several products are currently in late-stage of clinical development targeting H. pylori infection, medical device infections, hepatic encephalopathy and irritable bowel syndrome with diarrhea. The company is committed to address unmet needs in the disease area and provide safe and effective therapies for patients in China and around the world. For more information please visit: . SOURCE TenNor Therapeutics (Suzhou) Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

今日（11月18日），丹诺医药宣布其用于治疗幽门螺杆菌感染的全球首创新药TNP-2198成功完成III期临床试验并达到研究预设的主要终点指标，同铋剂四联相比体现多方面优势。 丹诺医药创始人马振坤博士表示：“TNP-2198是30年以来全球第一个专门针对幽门螺杆菌感染开发的抗菌新药，具有独特的多靶点协同作用机制。” 丹诺医药官微显示，这是一项多中心、随机、双盲、铋剂四联对照的III期临床试验，旨在评价TNP-2198联合阿莫西林和雷贝拉唑三联方案在初治患者中根除幽门螺杆菌的有效性和安全性。这项研究由北京大学第三医院周丽雅教授牵头，在全国40家医院开展。研究共纳入700例既往未接受过根除治疗、碳-13尿素呼气试验（UBT）阳性并经组织学确认的幽门螺杆菌感染者，患者按1:1随机分配至TNP-2198三联方案（试验组）或铋剂四联方案（对照组），接受每天2次，连续14天治疗，有效性终点为治疗结束后4~6周的UBT检测结果。 这项III期临床试验的整体执行情况良好，脱落率仅为3%，服药依从性高达96%，基线幽门螺杆菌培养成功率高达87%。试验组和对照组在人口学及基线药敏特征方面没有影响研究结果的显著差异。本研究中感染者克拉霉素、甲硝唑、左氧氟沙星和阿莫西林的耐药率分别达到41%、68%、35%和8%，与近期文献报道结果一致，表明中国幽门螺杆菌感染者中耐药问题严重。研究中未分离到对TNP-2198的耐药菌株。 有效性的主要分析人群为改良意向治疗分析集（mITT），即在随机分组后接受至少一次试验用药品治疗的感染者。TNP-2198三联方案在mITT人群中对幽门螺杆菌的根除率超过90%，高于铋剂四联对照（92.0%vs.87.9%，差值4.1%，非劣检验P<0.0001，优效检验P=0.0338）。在符合方案集（PP），即未发生影响疗效分析的重大方案违背的感染者中，TNP-2198三联方案的根除率同样高于铋剂四联（93.7%vs.90.3%，差值3.4%，非劣检验P<0.0001，优效检验P=0.0563）。在微生物学意向治疗分析集（Micro-ITT），即基线幽门螺杆菌培养阳性且有药敏试验结果的感染者中，基于药敏试验结果的任何抗生素耐药亚组（即对目前用于幽门螺杆菌根除的5种抗生素中的任何一个耐药）分析表明，TNP-2198三联方案对幽门螺杆菌的根除率仍超过90%，同样高于铋剂四联方案，与主要分析人群结果一致，表明TNP-2198三联方案对耐药感染具有良好的根除效果。 TNP-2198三联方案组在治疗期间发生的不良事件（TEAE）、试验用药品相关TEAE、3级及以上TEAE的发生率，均低于铋剂四联方案组，且大部分为1级，未出现与试验用药品相关的严重不良事件（SAE），表明TNP-2198三联方案具有良好的安全耐受性。 丹诺医药官微显示，TNP-2198是一个具有独特多靶点协同作用机制的抗菌新药候选物，拥有克服抗生素耐药、降低耐药频率和对慢代谢球形菌有效的优势，曾获得国家十三五“重大新药创制”科技重大专项的支持。丹诺医药已经完成TNP-2198的7项I-III期临床试验，并取得积极结果。丹诺医药拥有TNP-2198在美国的新药临床试验（IND）许可、美国FDA合格抗感染产品（QIDP）和快速通道（Fast Track）资格认定。 声明：本内容仅用作医药行业信息传播，不代表药智网立场。对本文有异议或投诉，请联系maxuelian@yaozh.com。 责任编辑 | 史蒂文  阅读原文，是受欢迎的文章哦