Acasti Pharma Reports Last Patient Visit in TRILOGY 1 Phase 3 Trial of CaPre for the Treatment of Severe Hypertriglyceridemia
LAVAL, Québec, Nov. 26, 2019 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), 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 (TGs) after 12 weeks compared to placebo. Safety and tolerability (e.g. overall adverse events (AE) and serious AE rate, any discontinuation due to AEs, and AEs of special interest such as gastrointestinal events) 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: 1) 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 (such as patients stratified with baseline qualifying TG levels of ≤750 mg/dL vs. >750 mg/dL), and a comparison of TG reduction in patients using and not using statins at baseline; 2) Non-HDL-C; 3) VLDL-C; 4) HDL-C; 5) LDL-C and HbA1c. Pierre Lemieux, Ph.D., COO and CSO of Acasti, commented, “We are pleased to report our “last patient, last visit” in TRILOGY 1, and we are nearing completion of TRILOGY 2 with approximately 85% of randomized patients having completed TRILOGY 2. Data clean-up is now 97% and 75% completed for TRILOGY 1 and TRILOGY 2, respectively. As a result, we are on track to report topline results for TRILOGY 1 in December 2019 and TRILOGY 2 in January 2020. Assuming these results are positive, we intend to present the full data set at important scientific meetings in the first half of 2020, and file an NDA by mid-2020 to obtain regulatory approval for CaPre in the United States.” About CaPre (omega-3 phospholipid)