Acasti Pharma reports last patient visit in TRILOGY 1 Phase 3 trial of CaPre
Acasti Pharma announced that the last patient completed their final visit in the Company's TRILOGY 1 pivotal Phase 3 trial of CaPre last week. Topline results for TRILOGY 1 are expected to be reported as planned in December 2019. The Company also expects the last patient to complete their final visit in TRILOGY 2 in early January 2020, with topline results expected towards the end of January 2020. Topline results will include a readout of the primary endpoint, which is intended to show CaPre's overall impact on lowering triglycerides after 12 weeks compared to placebo. Safety and tolerability will also be reported. The Company currently expects that topline results will not include any secondary or exploratory endpoints. The important secondary and exploratory endpoint results are expected to be completed before the end of March 2020, and will include: additional TG secondary endpoints, including TG reduction at Week 26, which is intended to show CaPre's persistence of effect, TG reduction in various subgroups to show consistency of effect, and a comparison of TG reduction in patients using and not using statins at baseline; Non-HDL-C; VLDL-C; HDL-C; LDL-C and HbA1c.