XNW4107 / Evopoint - LARVOL DELTA

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

Pharmacokinetics of XNW4107 in Subjects With Various Degrees of Renal Function (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Sinovent Pty Ltd.

Clinical • New P1 trial • Infectious Disease