LAVAL, Québec, Nov. 07, 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 (HTG), today announced the publication as Articles in Press of a CaPre pharmacokinetics study, entitled, “Evaluation of OM3-PL/FFA Pharmacokinetics After Single and Multiple Oral Doses in Healthy Volunteers” in a leading peer-reviewed journal, Clinical Therapeutics. The study publication is available online and can be accessed at: https://www.clinicaltherapeutics.com/article/S0149-2918(19)30499-0/fulltext .
In this Phase I, open-label, randomized, multiple-dose, single-center, parallel-design study, 42 healthy volunteers received a single dose of CaPre (OM3-PL/FFA) at day 1, followed by multiple oral doses of 1, 2, and 4 grams per day for 14 days. At day 15, all subjects received a high fat breakfast.Key findings included:CaPre was well tolerated in healthy subjects when administered as multiple oral doses of 1, 2, and 4 grams per dayCaPre’s PK parameters appeared to be approximately dose proportional over the 1-4 grams/day dose rangeThe bioavailability of CaPre did not appear to be meaningfully affected by the fat content of the meal consumed before dose administrationDr. Robert Hegele, Director of the Blackburn Cardiovascular Genetics Laboratory at Robarts Research Institute and co-author of the study, commented, “Although there are several approved prescription OM3 drugs for the treatment of severe HTG, there is need for a formulation with high bioavailability regardless of fat intake, since a low-fat diet is part of the management of patients with HTG. The study results for CaPre demonstrated greater exposure at higher doses, irrespective of fat content of the meal.”Pierre Lemieux, Ph.D., COO and CSO of Acasti, commented, “We are very pleased to have our study published in a leading peer-reviewed journal. This study further reinforces the favorable dose response reported in our prior clinical trials. This is important due to the fact patients randomized to CaPre in the TRILOGY trials all received 4 grams per day, compared to our Phase 2 studies that included a range of doses from 1 gram, 2 gram and 4 grams per day. Moreover, exposure was unaffected by fat content of the meal. This is an important distinction as current prescription omega-3s on the market are bound to ethyl-esters, which require patients to take their omega-3s with a high fat meal for ideal absorption, despite the fact patients with high triglycerides are advised by physicians to follow a restricted low-fat diet.”About CaPre (omega-3 phospholipid)
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