scholarly journals Dose Selection for Phase III Clinical Evaluation of Gepotidacin (GSK2140944) in the Treatment of Uncomplicated Urinary Tract Infections

2022 ◽  
Author(s):  
Nicole E. Scangarella-Oman ◽  
Mohammad Hossain ◽  
Jennifer L. Hoover ◽  
Caroline R. Perry ◽  
Courtney Tiffany ◽  
...  
Keyword(s):  
Urinary Tract ◽  
Urinary Tract Infections ◽  
Clinical Evaluation ◽  
Phase Iii ◽  
Current Standard ◽  
Dose Selection ◽  
Topoisomerase Iv ◽  
Double Blind ◽  
Selection For ◽  
Tract Infections

Antibiotics are the current standard of care treatment for uncomplicated urinary tract infections (uUTIs). However, increasing rates of bacterial antibiotic resistance necessitate novel therapeutic options. Gepotidacin is a first-in-class triazaacenaphthylene antibiotic that selectively inhibits bacterial DNA replication by interaction with the bacterial subunits of DNA gyrase (GyrA) and topoisomerase IV (ParC). Gepotidacin is currently in clinical development for the treatment of uUTIs and other infections. In this article, we review data for gepotidacin from nonclinical studies including: in-vitro activity, in-vivo animal efficacy, and pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) models that informed dose selection for phase III clinical evaluation of gepotidacin. Based on this translational package of data, a gepotidacin 1,500 mg oral dose twice-daily for 5 days was selected for two ongoing, randomized, multicenter, parallel-group, double-blind, double-dummy, active-comparator phase III clinical studies evaluating the safety and efficacy of gepotidacin in adolescent and adult female participants with uUTIs (NCT04020341 and NCT04187144).

scholarly journals UTI − quo vadis? New alternatives to treat uncomplicated urinary tract infections

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Kurt G. Naber ◽  
Zafer Tandogdu ◽  
Bela Köves ◽  
Gernot Bonkat ◽  
Florian Wagenlehner
Keyword(s):  
Antibiotic Resistance ◽  
Urinary Tract ◽  
Urinary Tract Infections ◽  
Case Reports ◽  
Randomized Study ◽  
Phase Iii ◽  
Double Blind ◽  
Quo Vadis ◽  
Tract Infections ◽  
The Impact

AbstractUrinary tract infections (UTI) are one of the most common problems in urology clinics. The European Association of Urology (EAU) has been pioneering in its efforts to disseminate the latest clinical findings through the organization of the annual EAU congresses. At this year’s congress (EAU Barcelona 2019), various satellite symposia were organized, focusing on specific issues in the field of urology. "UTI − quo vadis? New alternatives to treat uncomplicated urinary tract infections" was one of the industry-sponsored symposia, organized with the aim of evaluating the current scenario and also throwing light on the paradigm shift in the treatment of acute, uncomplicated lower urinary tract infections (uUTI). Several interlinking topics were presented during this symposium. The topics covered antibiotic resistance, involving a presentation of the current data from the Global Prevalence Study on Infections in Urology (GPIU-study). This discussion was followed by case reports on the impact of antibiotic resistance on the management of patients with UTI/uUTI and treatment options for UTI/uUTI according to current guidelines. The highlight of the symposium was the presentation of very recent data from a gold standard phase III clinical trial (double-blind, double-dummy randomized study), demonstrating the non-inferiority of a herbal medicine (BNO 1045) versus antibiotic therapy (fosfomycin trometamol (FT), as a single dose = 3 g) for the treatment of acute, uncomplicated cystitis.

scholarly journals UTI – Quo Vadis? New Alternatives to Treat Uncomplicated Urinary Tract Infections

Health of Man ◽  
2020 ◽  
Vol 0 (1) ◽  
pp. 19-25
Author(s):  
K. G. Naber ◽  
Z. Tandogdu ◽  
B. Köves ◽  
G. Bonkat ◽  
F. Wagenlehner
Keyword(s):  
Antibiotic Resistance ◽  
Urinary Tract ◽  
Urinary Tract Infections ◽  
Case Reports ◽  
Randomized Study ◽  
Phase Iii ◽  
Double Blind ◽  
Quo Vadis ◽  
Tract Infections ◽  
The Impact

Urinary tract infections (UTI) are one of the most common problems in urology clinics. The European Association of Urology (EAU) has been pioneering in its efforts to disseminate the latest clinical findings through the organization of the annual EAU congresses. At this year’s congress (EAU Barcelona 2019), various satellite symposia were organized, focusing on specific issues in the field of urology. “UTI – quo vadis? New alternatives to treat uncomplicated urinary tract infections” was one of the industry-sponsored symposia, organized with the aim of evaluating the current scenario and also throwing light on the paradigm shift in the treatment of acute, uncomplicated lower urinary tract infections (uUTI). Several interlinking topics were presented during this symposium. The topics covered antibiotic resistance, involving a presentation of the current data from the Global Prevalence Study on Infections in Urology (GPIU-study). This discussion was followed by case reports on the impact of antibiotic resistance on the management of patients with UTI/uUTI and treatment options for UTI/uUTI according to current guidelines. The highlight of the symposium was the presentation of very recent data from a gold standard phase III clinical trial (double-blind, double-dummy randomized study), demonstrating the non-inferiority of a herbal medicine( BNO 1045) versus antibiotic therapy (fosfomycin trometamol (FT), as a single dose = 3 g) for the treatment of acute, uncomplicated cystitis.

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