The Quebec-based biopharmaceutical company reported a 30.4% average reduction in triglyceride levels among all patients receiving CaPre, as compared to 30.5% in TRILOGY 1, and a 17.9% median reduction in triglyceride levels among patients receiving placebo at 12 weeks as compared to 27.5% in TRILOGY 1.
However, the company said unadjusted, placebo corrected triglyceride reduction of 12.4% achieved a “p” value of 0.19 – which was not statistically significant – meaning the TRILOGY 2 study did not meet its primary endpoint. As a result, Acasti said it will not file a New Drug Application with the US Food and Drug Administration for patients with severe hypertriglyceridemia, and does not plan to conduct additional clinical trials for CaPre.
READ: Acasti Pharma looking forward to the unblinding of its TRILOGY 2 trial data around end of this month
CaPre is a krill-oil derived prescription drug, aimed at treating hypertriglyceridemia, or high levels of triglycerides in the blood, which is known to contribute to heart disease.
Triglyceride reductions among patients taking CaPre were similar or larger than seen with prior omega-3 therapies compared to their baseline levels, according to the trial’s principal investigator Dr Dariush Mozaffarian, Professor at Tufts University, but an unusual reduction in triglyceride levels in the placebo group meant that statistical significance was not achieved.
The study group now plans to pool together the results from the two studies to see if they can better understand the phenomenon in post-hoc explorations, according to a release.
Jan D’Alvise, Acasti’s CEO, told shareholders that the firm was disappointed in the outcome of the Trilogy 2 study after preliminary topline data pointed to the fact that TRILOGY 2 was likely not affected by the same “pre-randomization triglyceride normalization effect” that was apparent in earlier studies.
“While the triglyceride reduction observed in the control arm was less than what was observed in the Trilogy 1 Study, it still remains one of the highest seen amongst the previously conducted triglyceride reduction studies, and may be explained by the excellent background standard of care that is being provided to these patients today,” D’Alvise said in a statement.
“We extend our sincere gratitude to all of the patients and their families, as well as the investigators who participated in this important trial, and to our employees who have worked tirelessly to develop and evaluate CaPre as a therapeutic for this indication.”
D’Alvise said that Acasti and its clinical advisors will review the full dataset once it is available, and will complete the full data analyses as contemplated in the statistical analysis plan, including the secondary and exploratory endpoints and the pooling of the data from TRILOGY 1 and 2.
“Taking into consideration all of the analyses from TRILOGY once completed, we will seek to maximize the value of the CaPre asset by continuing to explore a range of options available to us,” D’Alvise added.
Acasti said it will continue to evaluate all strategic options and will provide updates on this process as warranted.
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