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Antimicrob Agents Chemother. 2017 May 24;61(6). pii: e02095-16. doi: 10.1128/AAC.02095-16. Print 2017 Jun.

Efficacy, Safety, and Tolerability of Gepotidacin (GSK2140944) in the Treatment of Patients with Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections.

Author information

1
eStudySite, San Diego, California, USA.
2
GlaxoSmithKline, Upper Providence, Pennsylvania, USA Courtney.A.Tiffany@gsk.com Etienne.f.dumont@gsk.com.
3
GlaxoSmithKline, Upper Providence, Pennsylvania, USA.
4
GlaxoSmithKline, King of Prussia, Pennsylvania, USA.

Abstract

Gepotidacin is a novel, first-in-class, triazaacenaphthylene antibacterial agent which has in vitro activity against causative pathogens of acute bacterial skin and skin structure infections (ABSSSIs). This phase 2, randomized, 2-part, multicenter, dose-ranging, response-adaptive study with optional intravenous-oral switch evaluated the efficacy and safety of gepotidacin for the treatment of Gram-positive ABSSSIs in 122 adult patients in the United States. The study had a double-blind phase (part 1; intravenous [750 mg or 1,000 mg every 12 h {q12h}]) and an open-label phase (part 2; intravenous [750 mg q12h, 1,000 mg q12h, or 1,000 q8h]). The primary endpoint was a composite of efficacy and safety which consisted of the early cure rate and the withdrawal rate due to drug-related adverse events and utilized a clinical utility index for dose selection. At the early efficacy visit (48 to 72 h after the first dose), the 750-mg q12h and 1,000-mg q8h groups met prespecified success criteria for clinical utility in terms of efficacy and safety; however, the 1,000-mg q12h group did not meet these criteria due to observed lower efficacy rates. The most frequently reported adverse events were nausea (20%) and diarrhea (13%). These encouraging phase 2 results demonstrate the potential for gepotidacin to meet the medical need for novel antibacterial agents to treat ABSSSIs due to drug-resistant pathogens through a unique mechanism of action. (This study has been registered at ClinicalTrials.gov under registration no. NCT02045797.).

KEYWORDS:

ABSSSI; antibacterial agent; antimicrobial safety; efficacy; gepotidacin; phase 2 study; skin infections

PMID:
28373199
PMCID:
PMC5444153
DOI:
10.1128/AAC.02095-16
[Indexed for MEDLINE]
Free PMC Article

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