Enzocarb Injection

Project Description

ENZOCARB (cefepime-avibactam) is a novel antibiotic candidate developed by Nanjing YOKO Pharmaceutical, designed to treat carbapenem-resistant Klebsiella pneumoniae (CRKP) infections. Recent Phase 1 clinical data (2023) indicates it is safe and tolerable in healthy Chinese subjects with linear pharmacokinetics, supporting its potential for further clinical trials to fight drug-resistant pathogens. New Clinical & Pharmaceutical Developments for Enzocarb • Mechanism & Use: ENZOCARB combines cefepime (a cephalosporin) and avibactam (alpha beta ) lactamase inhibitor) to tackle multi-drug resistant Gram-negative bacteria, specifically carbapenem-resistant Klebsiella pneumoniae (CRKP). • Study Findings (2023): A phase 1 study in healthy Chinese subjects (NCT05588531) showed that the drug has a linear pharmacokinetic profile and does not accumulate after multiple doses. • Dosage Optimization: Based on Monte Carlo simulation (MCS) analysis, a dosage regimen of 2.5 g q8h intravenous infusion is recommended for future, late-phase clinical trials. • Superior Activity: Preliminary studies indicate that ENZOCARB shows improved bactericidal activity against polymyxin B-resistant CRKP compared to existing treatments like ceftazidime-avibactam. • Development Stage: The drug is developed by Nanjing YOKO Pharmaceutical Co., Ltd. and has moved through initial clinical trials in China for safety evaluation pharmacokinetic/pharmacodynamic analysis Results Cefepime and avibactam both showed a linear pharmacokinetic profile. No accumulation was found after multiple doses. The cefepime Cmax,ss and AUC0-∞,s were 9.20 and 16.0 μg/mL, 407.2 and 659.45 μg•h/mL in the 2.5 and 3.75 g multiple-dose groups, respectively. The avibactam Cmax,ss and AUC0-∞,ss were 0.545 and 0.837 μg/mL, 53.31 and 79.55 μg•h/mL in the 2.5 and 3.75 g multiple-dose groups, respectively. Cefepime and avibactam did not affect each other's pharmacokinetics. No serious adverse events occurred. All regimens achieved 90% probability of target attainment (PTA) goals when the MIC was ≤8 mg/L. The regimens of 2.5 (q8h, 2-h infusion), 3.75 (q8h, 2-, 3- and 4-h infusions) and 7.5 g (24-h continuous infusion) reached a 90% cumulative fraction of response.