leadf
logo-loader
viewAcasti Pharma Inc

Acasti Pharma leaps closer to TRILOGY 1 results after it wraps up patient visits

Acasti is conducting clinical trials on its prescription drug candidate CaPre, a highly purified omega-3 phospholipid concentrate

Acasti Pharma Inc -
Past studies have shown CaPre to achieve statistically significant reduction of triglycerides and non-HDL cholesterol levels in patients

Acasti Pharma Inc (NASDAQ:ACST) (CVE:ACST) is one step closer to revealing results from its critical TRILOGY 1 trial of lead drug CaPre, which treats severe hypertriglyceridemia. 

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. 

READ: Research firm Encode Ideas starts coverage on biotech Acasti Pharma

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.

Contact Angela at [email protected]

Follow her on Twitter @AHarmantas

Quick facts: Acasti Pharma Inc

Price: 0.39 CAD

TSX-V:ACST
Market: TSX-V
Market Cap: $37.79 m
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

In exchange for publishing services rendered by the Company on behalf of Acasti Pharma Inc named herein, including the promotion by the Company of Acasti Pharma Inc in any Content on the Site, the Company receives...

FOR OUR FULL DISCLAIMER CLICK HERE

Full interview: Acasti has 'put its finger on something very interesting' in...

Acasti Pharma Inc (NASDAQ:ACST)(CVE:ACST) COO Pierre Lemieux tells Proactive the last patient completed their final visit in its TRILOGY 1 trial of lead drug CaPre, which treats severe hypertriglyceridemia. Lemieux says the Quebec-based company is on its way to reporting results by the end of...

on 11/26/2019

2 min read