GSK presented positive results from two pivotal phase 3 trials for gepotidacin, an investigational antibiotic for uncomplicated urinary tract infections — bringing the drugmaker a step closer to having the first in a new class of oral antibiotics for the indication in over 20 years.
Gepotidacin is an investigational bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a novel mechanism of action and binding site and provides well-balanced inhibition of two different type II topoisomerase enzymes.
GSK's positive data from EAGLE-2 and EAGLE-3 was shared in a presentation at the European Congress of Clinical Microbiology and Infectious Diseases. In the EAGLE-2 trial, gepotidacin demonstrated therapeutic success in 50.6% of patients compared to 47% for nitrofurantoin. In the EAGLE-3 trial, gepotidacin demonstrated therapeutic success in 58.5% of patients compared to 43.6% for nitrofurantoin.
Following a recommendation made by an independent data monitoring committee back in November, both trials were stopped early for efficacy. "Gepotidacin is the first antibiotic to meet contemporary regulatory criteria, which set a high threshold for the efficacy of treatments in uncomplicated urinary tract infections," said Florian Martin Erich Wagenlehner, principal investigator for the EAGLE-2 trial.
The drugmaker plans to submit its application to the U.S. FDA in Q2 of 2023.
GSK’s infectious diseases portfolio represents about two-thirds of the company’s pipeline and the drugmaker has specifically invested in getting ahead of antimicrobial resistance.
The development of gepotidacin is the result of a 2013 public-private partnership between GSK and BARDA established with the aim to support the development of antibiotics to fight antibiotic resistance and bioterrorism.
Every year, more than 1.2 million people worldwide die from antibiotic-resistant infections, and if no action is taken, it’s estimated this number will grow to 10 million per year by 2050. The pace of innovative drug development has slowed to a crawl, while older antibiotics are rapidly losing ground in the fight against bacteria. And the results could be catastrophic for public health.