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Acasti Pharma reports Q1 EPS (15c), one est. (16c).

Jan D'Alvise, president and CEO of Acasti Pharma, commented, "Our TRILOGY Phase 3 trials in patients with severe hypertriglyceridemia 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 68% of the patients have now completed their 6-month plan. 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. 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. We have shared the statistical analysis plan for the analysis and reporting of the TRILOGY results with the FDA, and will finalize it 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."

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Publication:The Fly
Article Type:Financial report
Date:Aug 14, 2019
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