When Acasti Pharma’s lipid-fighting omega-3 med failed a phase 3 study in January, the company chalked that up to an “unusually large” placebo response. Now, the drug has missed the mark in a second phase 3 study, failing to beat placebo by a wide enough margin to hit the trial’s primary endpoint.
The culprit this time? Maybe the cholesterol-busting drugs, such as statins or PCSK9 inhibitors, patients were taking alongside the study medication or placebo, according to Acasti CEO Jan D’Alvise.
The study, TRILOGY 2, pitted the treatment, dubbed CaPre, against placebo in more than 200 patients with severe hypertriglyceridemia, or very high levels of fatty molecules called triglycerides. The results were on par with data reported from the earlier trial—patients taking the treatment saw a median decrease in triglyceride levels of 30.4% and 30.5%, respectively.
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Patients taking placebo posted an 17.9% reduction in triglycerides. Although this was lower than the 27.5% decrease reported in the earlier study, the “unusual” placebo effect meant that CaPre’s results did not reach statistical significance.
“Based on what we have seen in the preliminary topline data, we believe TRILOGY 2 was likely not affected by the same 'Pre-Randomization Triglyceride Normalization' effect that we saw in TRILOGY 1,” d’Alvise said in a statement. “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.”
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Acasti Pharma once hoped that CaPre could challenge Amarin’s Vascepa in the hypertriglydemia market. Now, it’s shelving its plans for an FDA filing and will instead analyze the results from both studies to understand what happened.
“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 said.