Clinical Trials

The drug is in late stage development in GSK’s infectious diseases portfolio and the positive data from the EAGLE-2 and EAGLE-3 phase 3 trials have been stopped early for efficacy following a recommendation from the Independent Data Monitoring Committee (IDMC) in November 2022.

The trial data was presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Copenhagen, Denmark, although full results are expected to be submitted for publication in a peer-reviewed journal later in 2023.

In both phase 3 trials, the drug demonstrated non-inferiority to nitrofurantoin, an existing treatment for uUTIs. In the EAGLE-3 trial, gepotidacin demonstrated statistically significant superiority compared to nitrofurantoin. Both results are based on a primary efficacy endpoint of therapeutic success, in the form of an eradication of bacteria at the Test-of-Cure visit 10-13 days after the beginning of the treatment.

The safety and tolerability profile of gepotidacin remained consistent with information from previous trials.

Chris Corsico, senior vice president of Development at GSK, commented: “Despite uUTIs being one of the most common infections in women and mounting concern about rising resistance rates to existing treatments, there has been no new class of antibiotics for over 20 years. We believe that gepotidacin, if approved, will offer a much-needed additional oral treatment option for patients at risk of treatment failure associated with resistance or recurrence of uUTI. We are committed to working with global regulators to bring this new antibiotic to patients as quickly as possible.”

Dr Florian Martin Erich Wagenlehner, principal investigator for the EAGLE-2 phase 3 trial, added: “These results are a significant step forward in an area that has seen very little innovation for decades. Gepotidacin is the first antibiotic to meet contemporary regulatory criteria, which set a high threshold for the efficacy of treatments in uUTIs. Gepotidacin has the potential to offer healthcare professionals another oral option to treat this common community infection.”