February 27, 2019/Suzhou/ -- TenNor Therapeutics Limited, a clinical-stage company focused on developing differentiated infectious disease products, announced that it has received US Food and Drug Administration (FDA) Qualified Infectious Disease Product (QIDP) designation for TNP-2092 powder for injection (TNP-2092 IV), for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI), Catheter Related Blood Stream Infections (CRBSI) and Prosthetic Joint Infections (PJI). Benefits available under QIDP designation include priority review, fast track and 5-year extension of market exclusivity. TNP-2092 IV is one of the leading products in TenNor’s new drug development portfolio. It is currently in Phase II clinical trials in the US. TNP-2092 is a highly differentiated product, not only active against pathogens that are resistant to available antibiotics (such as MRSA), but also active against bacteria living in biofilms. TNP-2092 IV has the potential to be used for the treatment of medical device associated bacterial biofilm infections, a major unmet medical need in infectious disease area currently requiring surgical intervention.
TenNor’s class I new drug, TNP-2198 capsule, has been approved by CDE for the initiation of clinical studies. This is TenNor’s another new pharmaceutical product entering clinical stage after TNP-2092 IV and TNP-2092 PO. TNP-2198 developed by TenNor is a novel and highly-differentiated antibiotic product, aiming at solving the major unmet clinical needs in the treatment of anaerobic and micro-aerobic bacterial infections. TNP-2198 is a multi-targeting new antimicrobial drug with global intellectual properties. It has unique antimicrobial activity against anaerobes and micro-aerobic bacteria. The infections caused by the anaerobic and micro-aerobic bacterial are closely associated with many common and major diseases. Nowadays, the choice of treatment for those diseases are very limited, mainly relying on drugs such as nitroimidazoles, which have been on the market for decades. The drug resistance has caused serious problems, which lead to high recurrence rate and low cure rate of the diseases. It is an urgent need for antibiotics with novel mechanism of actions. However, the pipeline of new antibiotics in global development against anaerobic and micro-aerobic bacterial infections is very weak. With unique multi-targeting and synergistic features, TNP-2198 has demonstrated good activity against clinical isolates, including drug-resistant bacterial strains. In comparing with existing anti-infective agents, TNP-2198 has the potential advantages in the treatment of Helicobacter pylori infection, bacterial vaginosis and Clostridium difficile infections. ‘This IND application was based on extensive preclinical studies’, said Xiangyi Xu, Director of Regulatory Affairs in TenNor, ‘Successful development of TNP-2198 will address important unmet needs in the field of anti-infections and we are expecting it to become a new therapeutic choice for anaerobic and micro-aerobic bacterial infections.’
TenNor held a kick-off meeting for the phase II clinical trial of TNP-2092 IV in San Francisco on Aug. 2, 2018. This product has been developed to solve the challenges of bacterial biofilm infections associated with implantable medical devices in clinic. The phase II trial will further evaluate the safety and effectiveness of the drug candidate. TNP-2092 is a multi-targeting New Molecular Entity specifically designed for the treatment of infections associated with bacterial biofilms and significantly differentiated from the current treatments. The compound exhibited potent activity against the major pathogens for the infections on implanted medical devices, including those that are resistant to the market antibiotics, and showed low propensity for the development of drug resistance. The compound also demonstrated excellent activity in multiple in vitro and in vivo biofilm models. ‘This project is an important part of our overall clinical plan based on the full communications with the FDA’, said Xiaomei Wang, VP of Clinical Operation in TenNor, ‘Successful development of TNP-2092 is expected to address unmet clinical needs in the field of anti-infections and has application prospect in the treatment of various medical device-associated infections.’