Tcm Biotech International (TPE:4169) said an independent review of the interim analysis for its Phase three trial of U101, an oral drug candidate to prevent recurrent urinary tract infections in women, recommended the study continue as planned.
The Independent Data Monitoring Committee found the trial's overall safety profile to be sound and recommended continuing patient enrollment, according to a Thursday Taiwan Exchange filing.
The company did not disclose efficacy or statistical results, in line with the trial protocol.
The trial aims to enroll 348 women, and is assessing U101's ability to prevent recurrent urinary tract infections over a 24-week treatment period.