TenNor Receives QIDP Designation for TNP-2092

时间:2019年02月27日    来源:admin

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.