Acasti’s shares plunge as new drug does not meet primary endpoint

pharmafile | January 14, 2020 | News story | Manufacturing and Production Acasti, Acasti Pharma, CaPre, Primary Endpoint, Shares 

Acasti Pharma’s shares plunged by as much as 67% this week as its drug CaPre failed to meet its primary endpoint. The drug was treating severe hypertriglyceridemia.

The TRILOGY 1 trial involved 245 patients with the condition. Patients were randomised to receive four capsules of the krill-oil-derived drug administered once a day for 26 weeks, or placebo.

Results showed that patients who had been given CaPre had a 30.5% median reduction in triglyceride levels, compared to a 27.5% reduction for placebo at 12 weeks.  At 26 weeks, patients receiveing statin therapy combined with CaPre had a median reduction of 42.2% versus 31.5% for placebo.

Acasti noted that both the CaPre and placebo arms of the TRILOGY 1 trial achieved significant reductions in triglycerides within the first four weeks from baseline, but the large response from the placebo placed the results under scrutiny.

CEO Jan D’Alvise, Chief Executive Officer of Acasti, said: “While we are encouraged by the magnitude of reduction in triglyceride levels seen among patients receiving CaPre, the large placebo effect was completely unexpected, and was about double what was seen in all other therapeutic hypertriglyceridemia trials.”

Acasti is evaluating possible explanations for the results. They do not believe the simple cornstarch used as placebo in TRILOGY 1 is likely to be the root cause for the high placebo response. Acasti is now awaiting results from the ongoing TRILOGY 2 trial, which are expected by the end of the month.

Conor Kavanagh


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