Acasti Pharma Provides Update on Timing of Topline Results for TRILOGY 1 Phase 3 Trial of CaPre
LAVAL, Québec, Dec. 23, 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), today announced that it expects to report its topline results for the TRILOGY 1 pivotal Phase 3 trial of CaPre in January 2020. The reporting of Trilogy 1 was postponed due to an unexpected delay in data processing and transfer from the central testing laboratory to the statistical consultants for independent and external validation. Acasti regrets the delay due to factors outside its control, and now anticipates to report topline results in January 2020. As requested by the Investment Industry Regulatory Organization of Canada (IIROC), due to market volatility, the Company indicates that it has no material update to provide at this time beyond the above timing update and independent and external validation exercise that is underway.
Implementation of the Trilogy 2 Study remains on track, and the Company continues to expect the last patient to complete their final visit in early January 2020, and expects to report topline results in Trilogy 2 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, and any discontinuation due to AEs) will also be reported. Other important secondary endpoints such as Non-HDL cholesterol, HDL cholesterol, and VLDL may now also be reported with the topline results. As previously disclosed, subgroup analyses of certain key secondary (LDL) and exploratory markers (HbA1c) will be dependent on combining results from both studies, and would be expected sometime later in the first quarter of 2020.
NOVEMBER ATM DISTRIBUTION UPDATE
Acasti also provided an update on its previously adopted at-the-market program (the “ATM Program”) for the month of November 2019, as required pursuant to the policies of the TSX Venture Exchange (the “November ATM Distribution”). Pursuant to the November ATM Distribution, Acasti issued an aggregate of 2,628,263 common shares of the Company (the “ATM Shares”) over the NASDAQ Stock Market for aggregate gross proceeds to the Company of US$5,693,057.27. The ATM Shares were sold at prevailing market prices which ranged from US$2.05 per share to US$2.27 per share. No securities were sold through the facilities of the TSX Venture Exchange or, to the knowledge of the Company, in Canada. The ATM Shares were sold pursuant to a U.S. registration statement on Form F-3 (No. 333-223464) as made effective on March 16, 2018, as well as an at-the-market issuance sales agreement dated February 14, 2019 among Acasti and B. Riley FBR, Inc. The ATM Shares sold pursuant to the November ATM Distribution were the first securities sold by Acasti under the ATM Program.
Acasti’s prescription drug candidate, CaPre, is a highly purified omega-3 phospholipid concentrate derived from krill oil, and is being developed to treat severe hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis. Its omega-3s, principally EPA and DHA, are either “free” or bound to phospholipids, which allows for better absorption into the body. Acasti believes that EPA and DHA are more efficiently transported by phospholipids sourced from krill oil than the EPA and DHA contained in fish oil that are transported either by triglycerides (as in dietary supplements) or as ethyl esters in other prescription omega-3 drugs, which must then undergo additional digestion before they are ready for transport in the bloodstream. Clinically, the phospholipids may not only improve the absorption, distribution, and metabolism of omega-3s, but they may also decrease the synthesis of LDL cholesterol in the liver, impede or block cholesterol absorption, and stimulate lipid secretion from bile. (Article from : www.drugs.com)