KBP-7072 is a global Phase 2-ready third generation aminomethylcycline for drug resistant infections across multiple indications, with a unique effect on Acinetobacter baumanni as well as Gram-positive bacterial strains such as MRSA, PRSP, and VRE. KBP-7072 has multiple regulatory incentives in place including Qualified Infectious Disease Product (QIDP) / Fast Track Designation from the U.S. FDA, which qualifies it for fast track approval, potential priority review, and an additional five years of exclusivity after approval.
KBP is utilizing U.S. government issued regulatory incentives such as the QIDP designation, in order to expedite KBP-7072’s potential approval in the U.S. Expedited U.S. approval can be leveraged to accelerate approval in China, a region with a large and growing anti-infectives market with significant untapped potential and high unmet medical.
· Strong antibacterial activity against gram negative bacteria including Acinetobacter (WHO priority pathogens, Priority 1/Critical)
· Completed Phase 1 trial and ready for global Phase 2
· FDA QIDP and Fast Track Designations awarded