Acasti Pharma Announces Additional Phase 3 Milestones Reached, and Remains on Track to Report Topline Results for TRILOGY 1 in December 2019 and TRILOGY 2 in January 2020

Acasti Pharma Announces Additional Phase 3 Milestones Reached, and Remains on Track to Report Topline Results for TRILOGY 1 in December 2019 and TRILOGY 2 in January 2020

Nearly 80% of randomized patients have completed the studies
Data clean-up for TRILOGY 1 is 90% completedPlan to present full data set including results for key secondary and exploratory endpoints of interest such as non-HDL-C, LDL-C, VLDL, HDL-C and HbA1c at key scientific meetings in 2020               LAVAL, Quebec, Sept. 30, 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, today reported additional milestones reached and provided a business update on its clinical trials.Pierre Lemieux, Ph.D., COO and CSO of Acasti, commented, “Our TRILOGY Phase 3 trials in patients with severe hypertriglyceridemia (triglyceride blood levels from 500 mg/dL to 1500 mg/dL) continue to progress, and we remain on track to report topline TRILOGY 1 results in December 2019, and topline TRILOGY 2 results in January 2020. Importantly, both of our TRILOGY studies have achieved 100% patient randomization, and nearly 80% of the patients in both studies combined have now completed their 6-month plan. It is important to note that data clean up is approximately 90% complete in TRILOGY 1, bringing us closer to database lock.  We have also progressed TRILOGY 2 and anticipate database lock as planned in January 2020.”Jan D’Alvise, president and CEO of Acasti, further noted, “Given the positive results we saw from our Phase 2 trials in a total of 675 patients, we eagerly await the completion of the results from our two TRILOGY clinical studies. It is also important to note:patients enrolled in the Phase 3 TRILOGY trials have higher baseline triglyceride levels (above 500 mg/dl) versus our Phase 2 studies, where most had baseline triglycerides significantly below 500 mg/dl;patients randomized to CaPre in the Phase 3 TRILOGY trials all received 4 grams per day and will remain on drug for 6 months, while our Phase 2 studies included patients receiving a range of doses from 1 gram, 2 grams and 4 grams per day for only 8 to 12 weeks with a favorable dose response;the Phase 2 trials also indicated that CaPre may have a positive effect on other major lipid markers such as VLDL, LDL-C, and HDL-C, as well as HbA1c in patients with diabetes.”As previously disclosed, 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. The placebo used in the TRILOGY trials is cornstarch, which is inert, and consequently is expected to have a neutral effect on key biomarkers of patients in the placebo group. The TRILOGY studies are designed to provide at least 90% statistical power to detect a difference of at least a 20% decrease from baseline in TGs between CaPre and placebo.The Company has shared the statistical analysis plan (SAP) for the analysis and reporting of the TRILOGY results with the FDA, and expects to finalize the SAP prior to final database lock. Subject to any input from the FDA, Acasti is currently planning that the topline TRILOGY results will include the primary endpoint of TG reduction at Week 12 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 follow shortly after the release of the topline results of TRILOGY 2, currently anticipated in late January, 2020. According to the SAP, the primary endpoint must first be positive with statistical significance prior to analyzing the secondary and exploratory endpoints. These endpoints will then be analyzed in the following order: 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.  Physician investigators determined if patients with high LDL-C and/or high HbA1c levels at screening needed to be put on standard therapy, and if so, they were stabilized prior to being randomized into TRILOGY. Results for both LDL-C and HbA1c will then require subgroup analyses, which are done by combining diabetic patients and separately patients with high LDL-C from both studies at baseline to reach adequate statistical power to detect a difference if one exists, and therefore potentially show any incremental benefit of CaPre above and beyond the standard of care. Acasti expects that the remaining secondary and exploratory endpoints along with various additional subgroup analyses should be completed before the end of March 2020.In addition to the preliminary topline data, the Company will seek to present the full data set, which will include results for key secondary and exploratory endpoints of interest such as Non-HDL-C, LDL-C, VLDL, HDL-C and HbA1c at key scientific meetings in 2020. The Company will communicate more information in the months ahead on how and when all of the TRILOGY results will be reported once the SAP is finalized.Jan D’Alvise concluded, “We are well capitalized beyond completion of our Phase 3 trials with over $25 million of cash as of June 30th, plus $8.1 million in additional proceeds from 5.9 million warrants exercised during the period from July 1 to August 12, 2019, which includes funding to progress preparation of the NDA, assuming the TRILOGY Phase 3 program is successful,  as well as expanded business and US commercial launch activities. Assuming our TRILOGY trials replicate our Phase 2 data, we believe CaPre has the potential to provide an attractive alternative to current therapies, and thus improve the lives of the millions of patients with cardiometabolic disease.”About CaPre (omega-3 phospholipid) 
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