November 11, 2019/Suzhou/China – TenNor Therapeutics released positive top-line results for TNP-2092 powder for injection from a phase II clinical trial conducted in the United States. TNP-2092 is currently under clinical development for the treatment of medical device associated bacterial biofilm infections. It has the potential to become the first drug approved for such infections.
This is a multicenter, randomized, double-blind, vancomycin-controlled phase II trial to evaluate the safety and efficacy of TNP-2092. The study enrolled 120 patients with acute bacterial skin and skin structure infection (ABSSSI) and randomized into TNP-2092 and vancomycin treatment groups in a 2:1 ratio. The early clinical response rates at early assessment point (within 48-72 hours after initiation of treatment, primary endpoint of FDA Guidance) in intent-to-treat (ITT) population were 76.3% for TNP-2092 and 67.5% for vancomycin. The post treatment success rates in the clinical evaluable (CE) population were 96.4% for TNP-2092 and 92.6% for vancomycin. The most common pathogens isolated from this study were methicillin-resistant Staphylococcus aureus (MRSA), accounting for about 50% of all strains isolated. In a sub-population analysis, TNP-2092 appeared to be equally efficacious against infections caused by MRSA and other pathogens. Incidence of treatment emerged adverse effects were similar between the two groups.
“This phase II trial is an important step in the overall clinical development plan for TNP-2092, and we are extremely excited about the outcomes”, said Dr. Zhenkun Ma, founder and CEO of TenNor Therapeutics, “we are currently planning to initiate phase III clinical development, including studies specifically targeting prosthetic joint infections.” “TNP-2092 has potential to address multiple unmet medical needs if successfully developed, for the treatment of “super bug” and medical device associated biofilm infections,” he added.
Medical devices such as prosthetic joints, central venous catheters and artificial heart valves are being inserted more frequently and biofilm infections associated with them have become a major unmet need. Biofilm infections are extremely difficult to eradicate and often require surgical interventions plus prolonged antibiotic treatment, leading to high treatment costs and patient suffering. TNP-2092 is a first-in-class multi-targeting drug conjugate, exerting its antibacterial activity by inhibiting three important drug targets: RNA polymerase, DNA gyrase and topoisomerase IV. TNP-2092 is characterized by having strong antibacterial activity, low frequency for development of resistance and excellent safety profile. Particularly, it has potential advantage in the treatment of medical device associated bacterial biofilm infections as compared to available therapies. TNP-2092 has received qualified infectious disease product (QIDP) and fast track designations from FDA.
About TenNor Therapeutics
TenNor Therapeutics is a clinical stage company focusing on global development of differentiated products for the treatment of diseases caused by bacterial infection or dysbiosis. TenNor possesses a strong new drug development portfolio targeting medical device associated bacterial biofilm infections, cirrhosis hepatic encephalopathy and Helicobacter pylori infection, to address unmet medical needs in these areas.