TWi Biotechnology Inc. today announced interim results from the ongoing Phase 2 proof of concept clinical study evaluating AC-201 CR as an oral uricosuric and anti-inflammatory agent for the treatment of hyperuricemia and prevention of gout flares combining with febuxostat, a xanthine oxidase inhibitor.
The interim analysis is for the first enrollment cohort (18 per arm completing Week 8), if the number of subjects in the AC-201 CR arm achieving the clinical target of sUA <6.0 mg/dL at Week 8 is at least 2 greater than the number in the placebo arm, then the remaining subjects will be enrolled in the second cohort; if not, enrollment will be stopped. Based on the report, the responders in AC-201 CR arm is at least 2 greater than the number in the placebo arm. In addition to producing the efficacy of AC-201 CR in gout patients, there have been no serious adverse events reported to date and AC-201 CR was generally safe and well tolerated in the study patients. Therefore, TWIB is able to continue to enroll second cohort subjects and complete this clinical trial in the end of 2016.
About the Study
The ongoing Phase 2a study (study code: AC-201-GOU-002) is an randomized, double-blind, placebo-controlled, multicenter study. This study is designed to test the urate-lowering effects, safety and tolerability of AC-201 controlled-release tablets (vs.placebo) in an initial dosing period as a monotherapy, followed by addition of febuxostat to test the efficacy and safety of the combination. At up to a maximum of 14 clinical sites in Taiwan, the study aims to enroll 140 eligible subjects, who are confirmed with gout, and who will be randomized in a 1:1 allocation ratio to either AC-201 CR or Placebo over a with a 12-week treatment period and a 4-week follow-up period.
The primary efficacy endpoint is the proportion of subjects achieving serum uric acid concentration <6.0 mg/dL at Week 8. The major secondary efficacy endpoints are proportion of subjects achieving serum uric acid concentration <6.0 mg/dL or <5.0 mg/dL at each visit; number of gout flares per subject during each period and overall.