The study, entitled “Evaluation of OM3-PL/FFA Pharmacokinetics After Single and Multiple Oral Doses in Healthy Volunteers,” was published in Clinical Therapeutics.
It found that CaPre, which treats severe hypertriglyceridemia, was well-tolerated in healthy subjects as multiple oral doses of one, two and four grams a day.
READ: Acasti Pharma on pace to release Phase 3 trial results of lead drug candidate CaPre in December
The study looked at 42 randomized healthy volunteers who received a single dose of CaPre for 14 days. On day 15, the subjects received a high-fat breakfast, which can contribute to hypertriglyceridemia (HTG), or elevated levels fat molecules in the bloodstream.
Other findings indicated that CaPre’s pharmacokinetic parameters appeared to be nearly dose-proportional over the 1 to 4 grams per day dose range.
Researchers also found that the bioavailability of CaPre did not appear to be affected by the fat content of the breakfast that was consumed by subjects on day 15.
The study’s co-author Dr Robert Hegele said that there is a need for a formulation with high bioavailability, regardless of fat intake, since a low-fat diet is part of the management of patients with HTG.
“The study results for CaPre demonstrated greater exposure at higher doses, irrespective of fat content of the meal,” Hegele said.
Acasti’s CEO Pierre Lemieux said that the study further enforced the favourable dose response reported in the company’s clinical trials. “This is important due to the fact patients randomized to CaPre in the TRILOGY trials all received 4 grams per day, compared to our Phase 2 studies that included a range of doses from 1 gram, 2 gram and 4 grams per day.”
Lemieux also told shareholders that exposure was unaffected by fat content of the meal, an “important distinction” as currently available prescription omega-3s are bound to ethyl-esters, which require patients to take their omega-3s with a high-fat meal for ideal absorption.
Laval, Quebec-based Acasti is on track to report topline results from its TRILOGY studies on CaPre in the next couple of months.
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