(Jinan, China, and Princeton, NJ) KBP BioSciences, a clinical stage biopharma company announced today that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for KBP-7072, a new generation tetracycline for resistant bacterial infections.
KBP-7072 obtained the QIDP and Fast Track designations based on treatment of community-acquired bacterial pneumonia (CAP), which affects millions of people each year, more and more were due to resistant bacteria. “Bacteria resistant to multiple classes of antibiotics are becoming a real threat to human society.” said Dr. Zhenhua Huang, Chairman of KBP BioSciences. “We started our journey years ago with KBP-7072. QIDP and Fast Track designations are good confirmation for our work. KBP-7072 can be an important treatment for CAP and other bacterial infections in the future.”
The QIDP designation makes KBP-7072 eligible to certain incentives provided under the Generating Antibiotic Incentives Now Act (GAIN Act) of 2012, including Priority Review and eligibility for an additional five-year exclusivity under the Hatch-Waxman Act. Fast Track designation confers expedited development and regulatory review of drugs intended to treat serious or life-threatening conditions where there are significant unmet medical needs.
In addition to CAP, there are many infections which become life-threatening due to the increasing problem of drug-resistant bacterial pathogen. KBP-7072 is being developed for several indications.
KBP-7072 is a new generation broad spectrum antibiotics aimed at multi-drug resistant bacteria. In addition to major resistant strains such as MRSA, PRSP, and VRE, KBP-7072 is highly potent against Acinetobacter, a Gram negative pathogen. The bacterium is increasingly common in hospital and community settings causing high mortality rate. There is no effective mono- or combo-therapy for this deadly pathogen. KBP-7072 has good PK profile, available in both oral and injectable formulations, making it ideal for various infections. Phase I trial in the US showed that KBP-7072 was safe and generally well tolerated. The oral formulation has good drug exposure, and long half-life in human. No GI adverse events were observed at the highest dose tried.
About KBP BioSciences
KBP BioSciences is a clinical stage biotech company dedicated to research, development and commercialization of innovative medicines for the global market. The company’s three clinical stage compounds have all obtained US FDA IND approvals.
KBP has developed a deep pipeline focused on meeting unmet medical needs globally. The company devotes its resources in three therapeutic areas, inflammation & autoimmune diseases, organ protection, and antibiotics. KBP has built a proprietary R&D platform aimed at discovery and development of global first-in-class compounds. The platform consists of a compound library which is the basis of new compound discovery; a bacterium library aimed at multi-drug resistant bacteria; and in vivo pharmacology platform for screening and testing new compounds.
Headquartered in Jinan, China, KBP BioSciences established its US affiliate in Princeton, New Jersey, which is responsible for clinical development and registration. The management team has decades of combined experiences in drug development and registration. We work with a world-class scientific advisory board to advance new therapies for significant unmet medical needs.
Invented in China for the world.