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更新于：2026-08-30
Evopoint Biosciences Co., Ltd.
更新于：2026-08-30
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NCT07707674
A Phase I, Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Efficacy of XNW28012 Monotherapy in the Treatment of Subjects With Metastatic Pancreatic Cancer
NCT07730580
An Open-Label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of XNW5004 Tablets in Combination With Anti-Tumor Therapy in Participants With Advanced Prostate Cancer
CTR20255163
评估XNW28012联合不同治疗方案治疗晚期恶性实体瘤受试者的安全性、耐受性和有效性的Ib/II期临床研究
100 项与 苏州信诺维医药科技股份有限公司 相关的临床结果
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2023-09-05The Journal of antimicrobial chemotherapy
Imipenem/funobactam (formerly XNW4107) in vivo pharmacodynamics against serine carbapenemase-producing Gram-negative bacteria: a novel modelling approach for time-dependent killing
Article
作者: Fratoni, Andrew J ; Wu, Yuchuan ; Abdelraouf, Kamilia ; Liu, Xiao ; Chen, Xi ; Berry, Angela V ; Nicolau, David P
Abstract:
Background:
Imipenem/funobactam (formerly XNW4107) is a novel β-lactam/β-lactamase inhibitor with activity against MDR Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacterales strains. Using a neutropenic murine thigh infection model, we aimed to determine the pharmacokinetic/pharmacodynamic (PK/PD) index, relative to funobactam exposure, that correlated most closely with the in vivo efficacy of imipenem/funobactam combination and the magnitude of index required for efficacy against serine carbapenemase-producing clinical strains.
Methods:
Dose-fractionation was conducted against three strains. Imipenem human-simulated regimen (HSR, 500 mg q6h 1 h infusion) efficacy in combination with escalating funobactam exposures against seven A. baumannii, four P. aeruginosa and four Klebsiella pneumoniae (imipenem/funobactam MICs 0.25–16 mg/L) was assessed as 24 h change in log10cfu/thigh.
Results:
Increased funobactam fractionation enhanced efficacy, indicating time-dependent killing. Changes in log10cfu/thigh versus %fT > MIC were poorly predictive of efficacy; bactericidal activity was observed at %fT > MIC = 0%. Across different threshold plasma funobactam concentrations (CTs), %fT > CT(1 mg/L) had the highest correlation with efficacy. Normalizing the %fT > CT = 1 mg/L index to the respective isolate imipenem/funobactam MIC ([%fT > CT]/MIC) allowed integration of the isolate’s susceptibility, which further enhanced the correlation. Median (%fT > CT[1 mg/L])/MIC values associated with 1-log reductions were 9.82 and 9.90 for A. baumannii and P. aeruginosa, respectively. Median (%fT > CT[1 mg/L])/MIC associated with stasis was 55.73 for K. pneumoniae. Imipenem/funobactam 500/250 mg q6h 1 h infusion HSR produced >1-log kill against 6/7 A. baumannii, 4/4 P. aeruginosa and stasis against 4/4 K. pneumoniae.
Conclusions:
Imipenem/funobactam showed potent in vivo efficacy against serine carbapenemase-producers. The novel PK/PD index (%fT > CT)/MIC appeared to best describe in vivo activity.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
Plasma and intrapulmonary pharmacokinetics of funobactam, a novel diazabicyclooctane β-lactamase inhibitor, administered in combination with imipenem/cilastatin in healthy subjects
Article
作者: Rodvold, Keith ; Gotfried, Mark ; Mamikonyan, Grigor ; Li, Jianguo ; Zhao, Hui ; Shi, Qifeng ; Xu, Allan ; Kocharyan, Aramayis ; Le, Meijie ; Hu, Ting
ABSTRACT:
Funobactam (formerly XNW4107) is a novel non-β-lactam diazabicyclooctane β-lactamase inhibitor with potent direct activity against Ambler classes A, C, and D β-lactamases. Imipenem in combination with funobactam exhibits robust activity against carbapenem-resistant
Enterobacterales
,
Acinetobacter baumannii
, and
Pseudomonas aeruginosa
. This study evaluated the intrapulmonary pharmacokinetics of funobactam, imipenem, and cilastatin in healthy subjects. Twenty participants received a 60 min intravenous infusion of imipenem 500 mg/cilastatin 500 mg combined with funobactam 250 mg every 6 h for five doses. Bronchoalveolar lavage (BAL) was performed at 1, 2, 4, or 6 h after the fifth dose (
n
= 5 per sampling time point) to determine epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations. The means from each plasma sampling time corresponding to the BAL sampling time were used to estimate the area under the curve from 0 to 6 h (AUC
0–6h
) for plasma, and mean concentrations from BAL sampling times from each cohort were used to estimate AUC
0–6h
for ELF and AM concentrations. Intrapulmonary penetration was assessed using AUC
0–6h
ratios of ELF and AM to unbound plasma. The AUC
0–6h
ratios of ELF to unbound plasma for funobactam, imipenem, and cilastatin were 35.2%, 31.8%, and 23.0%, respectively, and the AUC
0–6h
ratios of AM to unbound plasma were 36.6%, 16.8%, and 17.9%, respectively. Funobactam penetrated ELF and AM and exhibited higher intrapulmonary penetration than imipenem and cilastatin, supporting the clinical evaluation of funobactam in combination with imipenem for the treatment of nosocomial pneumonia.
This study is registered with ClinicalTrials.gov as
NCT04802863
.
100 项与 苏州信诺维医药科技股份有限公司 相关的药物交易
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100 项与 苏州信诺维医药科技股份有限公司 相关的转化医学
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