GSK Halts Enrollment in UTI Drug Candidate Trials, Plans FDA Filing

GSK has stopped enrollment in two phase 3 clinical trials evaluating its investigational drug gepotidacin in female adults and adolescents with uncomplicated urinary tract infections following early success in the studies.

In an interim analysis of efficacy and safety data in more than 3,000 patients, the trials met the primary efficacy endpoint of combined clinical and microbiological resolution following treatment.

An antibiotic that inhibits bacterial DNA replication, gepotidacin is the result of a public-private partnership between GSK, the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense.

Final study visits and data collection are anticipated during the first quarter of 2023. The company plans on initiating regulatory filings for gepotidacin in the first half of 2023.