The pharmaceutical company told shareholders on Tuesday that the last patient in the study completed their final visit, clearing the way to reporting results by the end of the year.
Laval, Quebec-based Acasti also said it expects the last patient to complete their final visit in the TRILOGY 2 study in early January 2020, with topline results expected towards the end of January 2020.
Acasti is conducting clinical trials on its prescription drug candidate CaPre, a highly purified omega-3 phospholipid concentrate stemming from krill oil to treat hypertriglyceridemia, or elevated levels of fat in the blood, that can lead to increased risk of cardiovascular disease and pancreatitis.
Past studies have shown CaPre to achieve statistically significant reduction of triglycerides and non-HDL cholesterol levels in patients with various levels of hypertriglyceridemia. CaPre also demonstrated potential to reduce cholesterol that is bad for the body and increase the type of cholesterol that the body needs.
Topline results from TRILOGY 1 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. Safety and tolerability, such as overall adverse events will also be reported.
TRILOGY studies nearing completion
Pierre Lemieux, Acasti’s CEO, told investors that the company is nearing completion of TRILOGY 2 with approximately 85% of randomized patients having completed the study.
Data clean-up is now 97% and 75% completed for TRILOGY 1 and TRILOGY 2, respectively, according to Lemieux.
“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,” Lemieux informed investors in a statement.
The important secondary and exploratory endpoint results are expected to be completed before the end of March 2020 and will include additional triglyceride secondary endpoints.
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