TenNor Therapeutics gets FDA orphan drug status for TNP-2092 in prosthetic joint infections

TenNor Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its multitargeting drug conjugate TNP-2092 for the treatment of prosthetic joint infections.

According to the Chinese biopharma company, biofilm infections associated with prosthetic joints, central venous catheters, artificial heart valves, and other medical devices has become a huge challenge.

Biofilm infections are very difficult to treat and usually need surgical intervention and prolonged antibiotic therapy, which results in high cost and significant impact to patient’s quality of life, said TenNor Therapeutics.

TNP-2092 has been designed to exert antibacterial activity by blocking three essential targets in bacterial biofilms – RNA polymerase, DNA gyrase, and topoisomerase IV.

Photo courtesy of The U.S. Food and Drug Administration/Wikipedia.org.

The multitargeting drug conjugate has shown strong bactericidal activity, low frequency for development of resistance apart from an excellent safety profile, claimed the Chinese biopharma company.

Also, TNP-2092 is said to have delivered better efficacy compared to standard of care in a range of animal models of bacterial biofilm infections.

Previously, TenNor Therapeutics was granted FDA qualified infectious disease product (QIDP) and fast track designations for the multitargeting drug conjugate.

Recently, the Chinese biopharma company wrapped up a phase 2 clinical trial for TNP-2092 in the US for the treatment of acute bacterial skin and skin structure infections (ABSSSI) which is said to have yielded positive results.