GSK reports EAGLE-2 and EAGLE-3 phase III trials met primary endpoint

GSK plc presented results from the pivotal EAGLE-2 and EAGLE-3 phase III trials for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urinary tract infections, or uUTI, in female adults and adolescents. The data were disclosed in an oral presentation at the European Congress of Clinical Microbiology and Infectious Diseases, or ECCMID, in Copenhagen, Denmark. In the EAGLE-2 and EAGLE-3 phase III trials, gepotidacin demonstrated non-inferiority to nitrofurantoin, an existing first-line treatment for uUTI, in patients with a confirmed uUTI and a uropathogen susceptible to nitrofurantoin. Additionally, in the EAGLE-3 phase III trial, gepotidacin demonstrated statistically significant superiority versus nitrofurantoin. These results are based on a primary efficacy endpoint of therapeutic success, an endpoint comprised of combined clinical resolution and microbiological eradication of bacteria at the Test-of-Cure visit 10-13 days after initiation of treatment. In the EAGLE-2 phase III trial, gepotidacin demonstrated therapeutic success in 50.6% of patients compared to 47% for nitrofurantoin. In the EAGLE-3 phase III trial, gepotidacin demonstrated therapeutic success in 58.5% of patients compared to 43.6% for nitrofurantoin. Across both trials, it was noted that 94% of patients treated with gepotidacin did not receive an additional antibiotic for uUTI during trial participation through the follow-up visit on day 28. The safety and tolerability profile of gepotidacin in the EAGLE-2 and EAGLE-3 phase III trials was consistent with previous trials of gepotidacin. Gepotidacin also demonstrated consistent efficacy compared to nitrofurantoin in key subgroups, including patients with Escherichia coli pathogens resistant to other antibiotics, those with a history of recurrence and those over 50 years old. "These positive data highlight GSK‘s world-leading infectious diseases portfolio, which represents about two-thirds of the Company’s pipeline. In addition, they reinforce GSK’s commitment to developing new antibiotics in high unmet medical need areas, such as uUTI. Today’s presentation follows the decision to stop the EAGLE-2 and EAGLE-3 pivotal trials early for efficacy following a recommendation made by the Independent Data Monitoring Committee in November 2022. The full results will be submitted for publication in a peer-reviewed scientific journal later this year," the company stated.