TenNor recevies FDA ODD for treating prosthetic joint infections
China based TenNor Therapeutics, a clinical-stage, global biopharmaceutical company has received FDA Orphan Drug Designation for TNP-2092 to treat prosthetic joint infections.
Medical devices such as prosthetic joints, central venous catheters and artificial heart valves are being used more frequently and biofilm infections associated with them have become a major challenge. Biofilm infections are extremely hard to treat and often require surgical intervention plus prolonged antibiotic therapy, leading to high cost and major impact to patient's quality of life.
TNP-2092 is a multitargeting drug conjugate, exerting antibacterial activity by inhibiting three essential targets in bacterial biofilms: RNA polymerase, DNA gyrase and topoisomerase IV. TNP-2092 has demonstrated strong bactericidal activity, low frequency for development of resistance and an excellent safety profile. TNP-2092 has shown better efficacy than standard of care in a variety of animal models of bacterial biofilm infections.
TenNor has previously received FDA Qualified Infectious Disease Product (QIDP) and Fast Track designations for TNP-2092. Recently, TenNor has completed a Phase II clinical trial for TNP-2092 in the United States for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and received positive results.