March 21, 2025 – TenNor Therapeutics announced the official initiation of a Phase II clinical trial for its first-in-class drug, TNP-2092, administered via intra-articular injection for the treatment of prosthetic joint infections (PJI). This significant milestone marks a crucial step forward for TenNor in addressing major unmet medical needs in the field of infectious diseases, offering new hope to millions of patients worldwide suffering from infections related to implanted medical devices.

Infections associated with implanted medical devices, such as PJI, represent a major unmet need. With the global aging population and advancements in medical technology, the use of implanted medical devices has become increasingly common, leading to a rising incidence of infections related to these devices. Implanted medical devices provide a unique environment for bacterial colonization and infection, including antibiotic-resistant bacteria. Bacteria can colonize the surface of implants and form biofilms, which effectively defend the action of antimicrobial drugs and the human immune response. These factors combine together, make the eradication of infections associated with implanted medical devices extremely challenging. Currently, the primary treatment option involves implant replacement surgery, supplemented by long-term antibiotic therapy, highlighting a major unmet medical need.

TNP-2092 is a novel antibacterial agent with a unique multi-target mechanism of action. It exerts bactericidal activity by synergistically inhibiting bacterial RNA polymerase, DNA gyrase, and topoisomerase IV. This mechanism offers advantages in overcoming antibiotic resistance, preventing the emergence of resistant strains, and providing bactericidal activity against biofilm infections. TNP-2092 is the only antibacterial drug candidate worldwide to have advanced to late-stage clinical trials for the treatment of prosthetic joint infections. The drug has previously been awarded the National Disruptive Technology Innovation Competition Prize for its potential in treating infections related to implanted medical devices. Additionally, it has received Qualified Infectious Disease Product (QIDP), Fast Track, and Orphan Drug designations from the U.S. FDA.

The newly initiated proof-of-concept Phase II clinical trial aims to evaluate the efficacy of intra-articular injection of TNP-2092 in treating early or acute PJI, with the goal of avoiding or reducing the need for replacement surgery. Intra-articular injection allows the drug to act directly on the infection site, significantly increasing local drug concentration while reducing systemic exposure and minimizing safety risks. The principal investigator of this study, Professor Cao Li, an internationally renowned PJI expert from the First Affiliated Hospital of Xinjiang Medical University, stated, "Treating prosthetic joint infections is a global challenge and an unmet clinical need. TNP-2092 has the potential to become a groundbreaking innovative therapy for the treatment of prosthetic joint infections, potentially replacing the current treatment paradigm dominated by debridement and replacement surgeries."

About TenNor Therapeutics

TenNor Therapeutics is a clinical-stage company specialized in the discovery and development of differentiated new drug products in diseases associated with bacterial infection and metabolism. TenNor possesses a unique multi-targeting drug conjugate technology platform and a strong new drug development pipeline with global IP protection. Several products are currently in late stage of clinical development, targeting H. pylori infection, implanted medical device infections, hepatic encephalopathy and irritable bowel syndrome with diarrhea. The company is committed to address the 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: www.tennorx.com