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 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.
