Rifasutenizol

— Phase IIb multicenter trial initiated, bringing this potential life-changing therapy closer to patients — SUZHOU, China, Sept. 10, 2026 /PRNewswire/ -- TenNor Therapeutics, a near-commercial-stage biotechnology company, today announced positive topline results from a Phase IIa proof-of-concept (POC) trial of rifaquizinone (TNP-2092), a first-in-class, triple-targeting drug candidate administered via intra-articular (IA) injection for the treatment of periprosthetic joint infection (PJI). The data suggest that TNP-2092 has the potential to cure PJI without surgical intervention—a paradigm shift that could fundamentally transform patient outcomes. Based on the findings, the company has initiated a multicenter Phase IIb trial to accelerate clinical development. The Unmet Need in PJI PJI is a devastating complication that can turn a successful joint arthroplasty into a medical and personal crisis. Approximately 45,000 new cases occur annually in the U.S. and 22,000 in China, yet treatment remains exceptionally challenging due to bacterial biofilm formation, which largely undermines the efficacy of conventional antibiotics. Surgical intervention is considered essential, as antibiotic‑only regimens carry unacceptably high failure rates. Patients currently face suboptimal surgical pathways: debridement, antibiotics, and implant retention (DAIR) for early postoperative (early) or acute hematogenous (acute) PJIs—with reported failure rates exceeding 30%—or a two-stage revision for chronic PJIs that requires multiple surgeries, extended hospitalization, and months of functional impairment, while still failing in over 10% of cases. The economic burden is staggering, with per-patient costs in the U.S. frequently surpassing $390,000. Compounding the challenge, the rising volume of joint replacements is driving a steep increase in PJI incidence; by 2035, an estimated 425,800 new PJI cases are expected globally—including 86,500 in China. Phase IIa Proof-of-Concept Trial Results This Phase IIa POC clinical trial, conducted in China, evaluated IA administration of TNP-2092 plus systemic antibiotic background therapy—without debridement or joint replacement—in patients with early or acute PJIs. Patients with chronic PJI requiring long-term antibiotic suppression therapy were also included in the study. As of July 1, 2026, data lock point (DLP) for interim analysis: 10 patients were enrolled. Seven patients with culture- or next-generation sequencing (NGS)-confirmed Gram-positive infections were included in the efficacy analysis. Two patients were excluded from the efficacy analysis due to culture-negative results. One patient had been newly enrolled as of the DLP, with efficacy data not yet available. Efficacy: Among the five patients with early or acute PJI who received TNP-2092 IA, all had completed the 6-month follow-up, with 100% (5/5) treatment success reported. Among the four patients who had completed the 12-month follow-up, 100% (4/4) treatment success was reported. Of the two patients with chronic PJI who received TNP-2092 IA and had completed the 6-month follow-up, 50% (1/2) treatment success was reported; 12-month follow-up data were pending as of the DLP. Safety: Nine patients were included in the safety analysis, with no TNP-2092-related treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) reported. The remaining patient, still undergoing follow-up, also reported no TNP-2092-related TEAEs or SAEs as of the DLP. These topline results demonstrate promising efficacy and a favorable safety profile for TNP-2092 IA, supporting the accelerated clinical development of this novel non-surgical approach to PJI treatment. Multicenter Phase IIb Trial Initiated A multicenter Phase IIb clinical trial to further evaluate TNP-2092 IA has received approval from China's National Medical Products Administration (NMPA), and the trial has recently been initiated. Expert Commentary Professor Li Cao, Chief Physician at the Orthopedics Center of the First Affiliated Hospital of Xinjiang Medical University, and the Principal Investigator for the POC trial: "PJI is a devastating condition, and currently, patients have very limited treatment options. TNP-2092 represents a paradigm shift in PJI therapy. The combination of TNP-2092, a novel biofilm-eradicating agent with intra-articular delivery offers the potential to cure PJI without subjecting patients to the painful, prolonged, and costly surgical pathway. I am extremely excited to see patients in this trial achieve cure—sparing them from the grueling surgical journey they would otherwise face." Professor Javad Parvizi, MD, FRCS, Professor of Orthopedic Surgery, Acibadem University, Istanbul, past president of the American Association of Hip and Knee Surgeons, and Co-Chair, International Consensus Meeting (ICM) on PJI: "Orthopedic surgery has seen remarkable breakthroughs that have changed countless lives—yet the management of PJI has remained stubbornly stagnant. The field is in urgent need of truly transformative innovation. I am excited by the proof-of-concept data for TNP-2092, which I believe has the potential to dramatically improve outcomes and quality of life for PJI patients." About Rifaquizinone (TNP-2092) TNP-2092 is a first-in-class, triple-targeting drug candidate specifically engineered to address the critical unmet need in implant-associated biofilm infections. Its distinct mechanism of action synergistically inhibits bacterial RNA polymerase, DNA gyrase, and topoisomerase IV—a triple-targeting approach that not only confers potent activity against resistant pathogens, including Methicillin-resistant Staphylococcus aureus (MRSA) and Quinolone-resistant S. aureus (QRSA), but also drives an exceptionally low resistance frequency of <10⁻¹². TNP-2092 has demonstrated potent biofilm bactericidal activity in both in vitro and in vivo models, outperforming current standard-of-care antibiotics. The company has successfully completed six Phase I and Phase II clinical trials in the United States and China, with TNP-2092 showing a favorable safety profile and excellent efficacy against acute bacterial skin and skin structure infections (ABSSSI). The U.S. Food and Drug Administration has granted TNP-2092 Qualified Infectious Disease Product (QIDP), Fast Track, and Orphan Drug designations for the treatment of PJI. Additionally, TNP-2092 received the Excellence Award at China's National Disruptive Technology Innovation Competition. About TenNor Therapeutics TenNor Therapeutics is a near-commercial-stage biotechnology company dedicated to the discovery, development, and commercialization of differentiated therapies to address unmet medical needs in disease areas associated with bacterial infections and bacterial metabolism. Empowered by its proprietary multi-targeting conjugate molecule technology, TenNor Therapeutics aims to deliver the best therapeutic solutions to overcome the limitations of conventional treatments and improve patient outcomes. As of June 30, 2026, TenNor Therapeutics had built a pipeline of eight innovative programs, including two Core Products: Rifasutenizol (TNP-2198) – a new molecular entity (NME) drug candidate used as part of a triple therapy for the treatment of Helicobacter pylori (H. pylori) infection. Rifaquizinone (TNP-2092) – a triple-targeting antibacterial drug candidate for the treatment of implant-associated bacterial infections, including periprosthetic joint infection (PJI), left ventricular assist device infection (LVADI), and catheter-related bloodstream infection (CRBSI). Forward-Looking Statements This press release contains forward-looking statements regarding TenNor Therapeutics' product development, clinical trial plans, and regulatory pathways. Actual results may differ materially due to various risks and uncertainties. TenNor undertakes no obligation to update these statements except as required by law. SOURCE TenNor Therapeutics (Suzhou) Limited 21% more press release views with Request a Demo

中国苏州——临近商业化阶段的生物技术公司丹诺医药今日宣布，其在研新药候选物利福喹酮（rifaquizinone，TNP-2092）通过关节腔内（intra-articular, IA）注射给药治疗人工关节感染（periprosthetic joint infection, PJI）的IIa期概念验证（proof-of-concept, POC）临床试验取得积极顶线结果，表明TNP-2092具备在无手术干预的情况下治愈PJI的潜力——这一突破性进展有望从根本上改变PJI患者的治疗格局。基于上述积极结果，公司已启动多中心IIb期临床试验，加速推进这一潜在颠覆性新药产品的临床开发。 PJI：亟待解决的重大未满足临床需求 PJI 是关节置换术后一种严重的并发症，可令原本成功的手术演变为医疗与个人的双重危机。美国每年新增PJI病例约45,000例，中国约22,000例，并且呈快速增长趋势。然而，由于细菌生物膜的形成导致传统抗菌药物的疗效显著降低，PJI的治疗面临极大挑战。目前，PJI的治疗以手术干预为主，单纯依靠抗菌药物治疗因失败率极高，临床上不予推荐。 目前PJI患者面临的治疗选择均为手术路径，但治疗效果并不理想：对于早期术后或急性血源性PJI，指南推荐施行清创、抗菌药物及假体保留手术方案（DAIR），但报道的失败率在30%以上；对于慢性PJI，则推荐进行二期翻修手术，该方案涉及多次手术、长期住院及术后数月的功能丧失，而失败率仍超过10%。PJI带来的经济负担极为沉重，美国每例患者的治疗费用通常超过39万美元。与此同时，关节置换手术量的持续增长进一步加剧了临床挑战，推动PJI发病率快速上升；据估算，到2035年全球每年新增PJI病例将达到425,800例，其中86,500例在中国。 IIa期概念验证临床试验结果 该项在中国开展的IIa期POC临床试验，评估了TNP-2092关节腔内注射（不进行清创或翻修手术）在早期术后、急性血源性或慢性（需长期抗生素抑制治疗）PJI患者中的疗效与安全性。 截至2026年7月1日数据锁定日（data lock point, DLP）的中期分析：共入组10例患者。其中7例经细菌培养或下一代基因测序（next-generation sequencing, NGS）确认为革兰氏阳性菌的感染者纳入疗效分析集；2例因培养阴性结果未纳入疗效分析；另有1例为DLP时新入组患者，尚无疗效数据。 疗效结果：在接受TNP-2092治疗的5例早期或急性PJI患者中，全部完成6个月随访，治疗成功率为100%（5/5）；其中4例完成12个月随访，治疗成功率亦为100%（4/4）。在接受TNP-2092治疗的2例慢性PJI患者中，完成6个月随访的2例中有1例治疗成功（50%），12个月随访数据截至DLP尚待获取。 安全性结果：共9例患者纳入安全性分析，研究中未报告与TNP-2092相关的治疗期不良事件（treatment-emergent adverse event, TEAE）或严重不良事件（serious adverse event, SAE）。其余1例仍在随访中的患者，截至DLP亦未报告与TNP-2092相关的TEAE或SAE。 以上研究结果显示了TNP-2092关节腔内注射给药治疗PJI的良好疗效和安全性特征，支持这一新型非手术PJI治疗药物的加速临床开发。 IIb期多中心临床试验已启动 为加快这一潜在颠覆性新药产品的临床开发，一项多中心IIb期临床试验方案已获中国国家药品监督管理局（NMPA）批准，该试验已于近期启动。 专家观点 曹力教授，新疆医科大学第一附属医院骨科中心主任，国际知名PJI专家，本POC临床试验主要研究者。 " PJI是一种治疗选择极度匮乏的严重疾病，当前标准疗法高度依赖手术。TNP-2092凭借其独特的生物膜清除能力，通过与关节腔内局部给药相结合，有望彻底改变PJI的治疗格局——让患者免于痛苦、漫长且昂贵的手术创伤。本次试验中，所有早期术后和急性血源性PJI患者在不进行手术干预下均取得治疗成功，令我们深受鼓舞，也进一步验证了这一创新疗法的临床潜力。" Javad Parvizi 教授，土耳其伊斯坦布尔 Acibadem 大学骨科教授，美国髋膝关节外科医师协会（AAHKS）前主席，PJI 国际共识会议（ICM）联合主席。 "骨科手术领域取得了诸多改变无数患者生命的重大突破——然而，PJI的治疗却长期停滞不前。该领域迫切需要真正的变革性创新。我对TNP-2092关节腔内注射治疗PJI的概念验证数据感到非常振奋，我相信该药物的成功开发，将显著改善PJI患者的治疗结局和生活质量。" 关于利福喹酮（TNP-2092） TNP-2092是一款全球首创、三靶点作用机制的在研新药，专门针对植入物相关生物膜感染这一重大未满足临床需求而设计。其独特的作用机制可协同抑制细菌 RNA 聚合酶、DNA 旋转酶和拓扑异构酶 IV——这一三靶点策略不仅能针对耐药病原体（包括耐甲氧西林金黄色葡萄球菌［MRSA］和耐喹诺酮金黄色葡萄球菌［QRSA］）展现强效抗菌活性，还能将耐药频率降至极低水平（<10⁻¹²）。 在临床前研究中，TNP-2092在体外和体内模型中均展现出强效的生物膜杀菌活性，效果明显优于当前标准治疗抗菌药物。公司已在美国和中国成功完成六项 I 期和 II 期临床试验，TNP-2092 展现出良好的安全性并在急性细菌性皮肤及皮肤结构感染（ABSSSI）中显示出良好的疗效。 TNP-2092 的变革性潜力已获得监管机构的高度认可。美国食品药品监督管理局（FDA）已授予 TNP-2092 合格感染性疾病产品（QIDP）、快速通道（Fast Track）及孤儿药资格认定。此外，TNP-2092 还荣获中国全国颠覆性技术创新大赛优胜奖。 媒体联络： 邮箱: IR@tennorx.com 电话: +86 (0512) 8686 1986 前瞻性声明 本新闻稿包含关于丹诺医药产品开发、临床试验计划及监管路径的前瞻性陈述。实际结果可能因各种风险和不确定性而与前瞻性陈述存在差异。除法律要求外，丹诺医药不承担更新这些陈述的义务。 关于丹诺医药 丹诺医药（6872.HK）于2013年注册成立，是一家临近商业化阶段的生物科技公司，专注于发现、开发及商业化差异化的创新药产品，以解决细菌感染及细菌代谢相关疾病领域的未被满足临床需求。凭借自主开发的多靶点偶联分子技术，丹诺致力于为患者提供最佳治疗方案，以克服传统治疗的局限性并改善患者预后。截至2026年6月30日，公司已建立一条由八项创新项目组成的管线，包括两项核心产品：利福特尼唑(TNP-2198)，一款多靶点偶联新分子实体（NME）候选药物，通过与阿莫西林和质子泵抑制剂联合使用治疗幽门螺杆菌感染，亦作为单药疗法治疗细菌性阴道病及艰难梭菌感染；及利福喹酮（TNP-2092注射剂），一款三靶点NME候选药物，用于治疗急性细菌性皮肤及皮肤结构感染和植入体相关细菌感染（如人工关节感染、左心室辅助装置感染及中心静脉导管相关血流感染）。 如需更多信息，请访问：www.tennortherapeutics.com