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Acasti Pharma Shares Drop 54% on Disappointing Trial Results >ACST
6:31 am ET January 13, 2020 (Dow Jones) Print

By Chris Wack

Acasti Pharma Inc. (ACST) shares dropped 54% to $1 after the company reported topline results for the primary endpoint, triglyceride reduction at 12 and 26 weeks, from its Phase 3 Trilogy 1 trial for its lead product candidate, CaPre, came in close to the placebo arm.

The biopharmaceutical company said the study showed a 30.5% median reduction in triglyceride levels among all patients receiving CaPre, compared with a 27.5% median reduction in triglyceride levels among patients receiving placebo at 12 weeks.

The company also reported a 42.2% median reduction in triglycerides among patients receiving CaPre while on background statin therapy at 12 weeks, compared with a 31.5% median reduction in triglyceride levels among patients receiving placebo and on background statin therapy. In addition, the company reported a 36.7% median reduction in triglyceride levels among patients receiving CaPre at 26 weeks (end of the study), compared with a 28.0% median reduction in triglyceride levels among patients receiving placebo.

Acasti said both the placebo and CaPre study groups experienced significant reductions in triglycerides within the first four weeks from baseline, and even though the difference at 12 and 26 weeks was in favor of CaPre, due to the unexpectedly large placebo response, Trilogy 1 didn't reach statistical significance.

The company said the safety profile of CaPre in Trilogy 1 was similar to placebo, as there were no significant difference in treatment-related serious adverse events in the trial. Results for all of the secondary and exploratory endpoints were delayed as previously reported on Dec. 23, and are expected to be available by the end of the first quarter.

Acasti said the observed reductions in triglyceride levels in the placebo group were far greater than that seen in any previous triglyceride lowering trial with a prescription omega-3. The placebo used in the Trilogy trials is simple cornstarch, which is a complex carbohydrate with a low glycemic index, and consequently would be expected to have a neutral effect on key biomarkers of patients in the placebo group.

Write to Chris Wack at [e-mail]