Tai-Chung Announces Interim Analysis Results of Phase III Trial for Recurrent UTI Drug, Safety Confirmed, Trial to Continue

Tai-Chung (4169-TW) held a press conference today (23rd) to announce the interim analysis results of the Phase III clinical trial in Taiwan for U101, its investigational drug for preventing recurrent urinary tract infections (rUTI). The External Independent Data Monitoring Committee (IDMC) reviewed the data and confirmed that the overall trial safety profile is acceptable, recommending that the trial continue as originally planned. The company will proceed with enrollment toward the target of 348 participants.

According to Tai-Chung, the Phase III trial of U101 in Taiwan spans 48 weeks, divided into two major phases: the 'Main Study' and the 'Open-Label Extension (OLE)'. The Main Study lasts 24 weeks and follows a randomized, double-blind, placebo-controlled design. Participants who meet the criteria in the subsequent OLE phase will continue receiving U101 treatment for another 24 weeks to further evaluate long-term efficacy and safety.

Per the trial protocol, the interim analysis was triggered when 60% of participants—208 individuals—completed 24 weeks of treatment or experienced at least one urinary tract infection episode.

Tai-Chung stated that following the IDMC's completion of the interim analysis, the committee recommended continuing the Phase III clinical trial as originally planned. This indicates no safety issues or other major concerns requiring trial termination or design modifications have been identified at this stage, supporting the continuation of the trial to final analysis.

Additionally, Tai-Chung is advancing its global strategy. Its U.S. subsidiary, TCM Life Science Inc., plans to submit an IND application to the U.S. FDA for the Phase III clinical trial of U101 in the second half of this year, with clinical enrollment in the United States scheduled to begin in the first half of next year.