TWi Biotechnology, Inc. announced that it has completed patient enrollment in its Phase 2 clinical trial (Study code: AC-201CR-HA-001) of AC-201CR for the treatment of hemophilic arthropathy. The Company expects to release top-line results from the interim analysis of this study in the second quarter of 2019. The multi-center, double-blind, randomized, placebo-control proof-of-concept Phase 2 study was launched in Taiwan in the fourth quarter of 2016 and designed to evaluate AC-201CR's efficacy, safety and tolerability in up to 22 individuals with hemophilic arthropathy. AC-201CR-HA-001 study was composed of 3 sequential treatment periods of total 48 weeks. In Period 1, subjects were randomized in a 1:1 ratio to receive QD treatment of AC-201CR or placebo for 4 weeks. In Period 2, subjects titrated to BID regimen of blinded study medication for 20 weeks. In Period 3, all subjects discontinued blinded study medication and started open-label QD treatment with AC-201CR for 4 weeks followed by dose titration to BID for the remaining 20 weeks. The primary endpoint of the study will be assessed by change from baseline in IPSG (MRI) score for primary knee to evaluate joint structure-modifying effects of AC-201CR. Other secondary endpoints in the Phase 2 study to evaluate efficacy include MRI-measured synovial membrane thickness by knee, knee pain (by VAS), quality of life and safety.