Acasti: CaPre Trial Fails To Meet Endpoint On Unusually Large Placebo Effect

Acasti Pharma Inc. (ACST) reported topline results from its phase 3 TRILOGY 1 trial for the lead product candidate, CaPre, being developed to treat severe hypertriglyceridemia. In the study, 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 did not reach statistical significance.

The company noted that 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. A high placebo response at 5 sites disproportionately contributed to the overall placebo response.

Acasti Pharma said the implementation of the TRILOGY 2 study remains on track. However, there could be a small delay of a couple weeks in reporting topline results for TRILOGY 2 to mid-February 2020.

Shares of Acasti Pharma Inc. were down nearly 60% in pre-market trade on Monday.

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