XNW4107 / Evopoint - LARVOL DELTA

In Vitro Activity of Imipenem-Funobactam Against Clinical Isolates of Gram-Negative Bacilli. (PubMed, Antibiotics (Basel)) - "Objectives: The intent of this study was to report reference in vitro antimicrobial susceptibility testing results for funobactam (formerly XNW4107) in combination with imipenem against recent, worldwide clinical isolates of Gram-negative bacilli... Imipenem-funobactam demonstrated potent in vitro activity against most carbapenem-resistant isolates of A. baumannii, K. pneumoniae, NME and many isolates of carbapenem-resistant P. aeruginosa. Continued development of imipenem-funobactam is warranted."

Journal • Preclinical • Infectious Disease • Pneumonia

Impact of renal impairment on pharmacokinetics, safety, and tolerability of funobactam, combined with imipenem and cilastatin. (PubMed, Antimicrob Agents Chemother) - P1 | "The treatment was well tolerated, with no deaths, severe adverse events, or discontinuation due to adverse events. Dosage adjustments of funobactam, imipenem, and cilastatin will be needed in patients with renal impairment or ESRD requiring HD.CLINICAL TRIALSThis study is registered with ClinicalTrials.gov as NCT04787562."

Journal • PK/PD data • Chronic Kidney Disease • Nephrology • Renal Disease

Plasma and intrapulmonary pharmacokinetics of funobactam, a novel diazabicyclooctane β-lactamase inhibitor, administered in combination with imipenem/cilastatin in healthy subjects. (PubMed, Antimicrob Agents Chemother) - P1 | "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. The AUC0-6h ratios of ELF to unbound plasma for funobactam, imipenem, and cilastatin were 35.2%, 31.8%, and 23.0%, respectively, and the AUC0-6h 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."

Journal • PK/PD data • Infectious Disease • Pneumonia • Respiratory Diseases

In vitro activity of funobactam (XNW4107) in combination with imipenem against Gram-negative isolates collected in 2022 (ESCMID Global 2026) - No abstract available

Combination therapy • Gram negative • Preclinical • Infectious Disease

Antibiotics and non-traditional antimicrobial agents for carbapenem-resistant Acinetobacter baumannii in Phase 1, 2, and 3 clinical trials. (PubMed, Expert Opin Investig Drugs) - "Specifically, 9 antibiotics are in Phase 1 (R-327, xeruborbactam/QPX-7728, upleganan/SPR-206, MRX-8, QPX-9003, zifanocycline/KBP-7072, apramycin/EBL-1003, zosurabalpin/RG-6006, and ANT-3310), two in Phase 2 (BV-100, OMN-6), and two in Phase 3 (zidebactam/WCK-5222, funobactam/XNW-4107) clinical trials...In particular, two monoclonal antibodies (TRL-1068, CMTX-101), a phage therapy (Phagebank), an immune-modulating agent (recombinant human plasma gelsolin/Rhu-pGSN), a microbiome-modulating agent (SER-155), and an engineered cationic antibiotic peptide (PLG-0206). Several agents with promising characteristics against CRAB infections are in clinical development (Phases 1, 2, and 3). The urgent need for therapeutic options against CRAB infections necessitates optimizing efforts and time for introducing successfully studied agents into clinical practice."

Journal • Review • Infectious Disease • GSN

Imipenem/Cilastatin-XNW4107 Versus Imipenem/Cilastatin/Relebactam for Treatment of Participants with Bacterial Pneumonia (XNW4107-302, REITAB-2) (clinicaltrials.gov) - P3 | N=450 | Completed | Sponsor: Evopoint Biosciences Inc. | Trial completion date: Dec 2025 ➔ Sep 2024 | Trial primary completion date: Apr 2025 ➔ Sep 2024 | Recruiting ➔ Completed

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Pneumonia • Respiratory Diseases

In vitro activity of funobactam (XNW4107) combined with imipenem against Gram-negative isolates collected in 2021 (ECCMID 2024) - No abstract available

Gram negative • Preclinical • Infectious Disease

Imipenem/funobactam (formerly XNW4107) in vivo pharmacodynamics against serine carbapenemase-producing Gram-negative bacteria: a novel modelling approach for time-dependent killing. (PubMed, J Antimicrob Chemother) - "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."

Gram negative • Journal • PK/PD data • Preclinical • Infectious Disease • Pneumonia

Pharmacokinetics of XNW4107 in Subjects With Various Degrees of Renal Function (clinicaltrials.gov) - P1 | N=39 | Completed | Sponsor: Evopoint Biosciences Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

To Evaluate the Pharmacokinetics of XNW4107 in Healthy Adult Young Females and in Healthy Adult Elderly Males and Females. (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Evopoint Biosciences Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

Evaluation of the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP (EudraCT no. 2022-000061-40) (clinicaltrials.gov) - P3 | N=780 | Not yet recruiting | Sponsor: Evopoint Biosciences Inc. | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Infectious Disease • Nephrology

Evaluation of the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Recarbrio in Adults With HABP /VABP (EudraCT no. 2022-000081-18) (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Sinovent Pty Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Apr 2024 ➔ Apr 2025

Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Pneumonia • Respiratory Diseases

In vivo Activity of Imipenem/XNW4107 Human-Simulated Regimen against Serine Carbapenemase-Producing Acinetobacter baumannii and Pseudomonas aeruginosa in the Neutropenic Murine Thigh Infection Model (IDWeek 2022) - No abstract available

Preclinical • Infectious Disease

In Vitro and In Vivo Activities of a Novel β-Lactamase Inhibitor Combination Imipenem/XNW4107 against Recent Clinical Gram-negative Bacilli from China. (PubMed, J Glob Antimicrob Resist) - "The broad-spectrum profile and potent in vitro and in vivo antibacterial activities support imipenem/XNW4107 as a promising investigational candidate."

Journal • Preclinical • Infectious Disease • Pneumonia

To Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Recarbrio in Adults With HABP /VABP (clinicaltrials.gov) - P3; N=380; Not yet recruiting; Sponsor: Sinovent Pty Ltd.

New P3 trial • Infectious Disease • Pneumonia • Respiratory Diseases

To Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP (clinicaltrials.gov) - P3; N=780; Not yet recruiting; Sponsor: Sinovent Pty Ltd.

New P3 trial • Infectious Disease • Nephrology

To Evaluate the Pharmacokinetics of XNW4107 in Healthy Adult Young Females and in Healthy Adult Elderly Males and Females. (clinicaltrials.gov) - P1; N=24; Active, not recruiting; Sponsor: Sinovent Pty Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease

Pharmacokinetics of XNW4107 in Subjects With Various Degrees of Renal Function (clinicaltrials.gov) - P1; N=39; Active, not recruiting; Sponsor: Sinovent Pty Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease

Intrapulmonary Pharmacokinetics of XNW4107, Imipenem and Cilastatin in Healthy Subjects (clinicaltrials.gov) - P1; N=21; Completed; Sponsor: Sinovent Pty Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease

Study to Evaluate Safety, Tolerability, and Pharmacokinetics of XNW4107 Alone or in Combination With Imipenem/Cilastatin (clinicaltrials.gov) - P1; N=84; Completed; Sponsor: Sinovent Pty Ltd.; Recruiting ➔ Completed; Trial primary completion date: Sep 2021 ➔ Feb 2021

Clinical • Combination therapy • Trial completion • Trial primary completion date • Infectious Disease

Study to Evaluate Safety, Tolerability, and Pharmacokinetics of XNW4107 Alone or in Combination With Imipenem/Cilastatin (clinicaltrials.gov) - P1; N=84; Recruiting; Sponsor: Sinovent Pty Ltd.; Trial primary completion date: Apr 2021 ➔ Sep 2021

Clinical • Combination therapy • Trial primary completion date • Infectious Disease

Intrapulmonary Pharmacokinetics of XNW4107, Imipenem and Cilastatin in Healthy Subjects (clinicaltrials.gov) - P1; N=20; Active, not recruiting; Sponsor: Sinovent Pty Ltd.; Not yet recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease

Intrapulmonary Pharmacokinetics of XNW4107, Imipenem and Cilastatin in Healthy Subjects (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Sinovent Pty Ltd.

Clinical • New P1 trial • Infectious Disease

To Evaluate the Pharmacokinetics of XNW4107 in Healthy Adult Young Females and in Healthy Adult Elderly Males and Females. (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Sinovent Pty Ltd.

Clinical • New P1 trial • Infectious Disease

Study to Evaluate Safety, Tolerability, and Pharmacokinetics of XNW4107 Alone or in Combination With Imipenem/Cilastatin (clinicaltrials.gov) - P1; N=84; Recruiting; Sponsor: Sinovent Pty Ltd.; Trial completion date: Mar 2021 ➔ Jul 2021; Trial primary completion date: Jan 2021 ➔ Apr 2021

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Infectious Disease