GSK’s Oral Antibiotic Showcases Potency Against Resistant Gonorrhea in Late-Stage Trial
- GSK's experimental antibiotic, gepotidacin, demonstrates noninferiority to the current standard treatment for gonorrhea during the EAGLE-1 phase 3 trial involving around 600 patients with uncomplicated urogenital gonorrhea.
- Two 3,000 mg daily doses of oral gepotidacin for five days were administered along with a single intramuscular injection of ceftriaxone and an oral azithromycin dose.
- The study's primary endpoint, which measured microbiological response between three and seven days post-treatment, indicated that gepotidacin was noninferior to the established treatment.
- Gepotidacin, part of a new class of chemical antibiotics called triazaacenaphthylene bacterial topoisomerase inhibitors, has been in development since 2013 amid concerns over rising resistance to existing treatments.
- GSK plans to present detailed results at an upcoming scientific meeting and share them with global health authorities.
- Gepotidacin's safety and tolerability profile aligns with findings from phases 1 and 2 trials.
- GSK intends to pursue approvals for both UTIs and gonorrhea indications later this year.
- The company has faced delays in their initial timeline for seeking regulatory approval, with decisions on UTI use anticipated in 2025.