September 13, 2023 – TenNor Therapeutics announced that the National Medical Products Administration (NMPA) has approved the Phase I/II clinical trial of TNP-2092 for intra-articular injection (TNP-2092 IA) for the treatment of prosthetic joint infections (PJI).

TNP-2092 is a multi-targeting drug conjugate designed and developed for the treatment of biofilm infections associated with implanted medical devices. It exerts its bactericidal activity against bacterial biofilms by inhibiting three essential drug targets: bacterial RNA polymerase, DNA gyrase and topoisomerase IV, and has a low propensity for the development of drug resistance. TNP-2092 for injection (TNP-2092 IV) has received FDA’s Qualified Infectious Disease Product (QIDP), Fast Track and Orphan Drug designation. TenNor has completed six Phase I/II clinical trials of TNP-2092 IV in the United States and China and demonstrated the safety and efficacy of TNP-2092 IV. TenNor has received the approval from the US FDA and China NMPA to conduct two multiregional clinical trials (MRCT) of TNP-2092 IV for the treatment of PJIs and acute bacterial skin and skin structure infections (ABSSSIs).

Preclinical studies indicate that the intraarticular delivery of TNP-2092 can increase drug concentration at the site of infection and in the same time reduce the systemic exposure. TNP-2092 IA has potential to further improve the safety and efficacy of TNP-2092 for the treatment of PJIs.

With population aging, more and more people undergo total joint arthroplasty. The treatment of accompanying PJIs has become an important unmet need. Bacteria form biofilms on the surface of the implants, effectively preventing the killing effects of current antibiotics and immune responses. Currently, replacement surgery is the standard treatment for PJIs, which is expensive and has major impact to patient’s quality of life. With its novel multi-targeting mechanism of action and favorable drug distribution characteristics, TNP-2092 has the potential to become the first product for the treatment of PJIs and other implanted medical device infections. The successful development of TNP-2092 could potentially save healthcare costs and improve the quality of life of patients.

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