Neptune Technologies & Bioressources's subsidiary Acasti Pharma has reported positive data from a Phase II randomised, open-label, dose-ranging, multicentre trial of investigational CaPre, to treat mild to severe hypertriglyceridemia.
CaPre was found to be safe and effective with significant mean triglyceride reductions above 20% after eight weeks of treatment, with both daily doses of 4g and 2g against standard of care, thereby meeting the study's primary objective.
Acasti business and scientific affairs executive vice president Dr Harlan Waksal said investigational new drug CaPre is showing significant statistical and clinical benefits in treating mild to moderate hypertriglyceridemia patients.
"This harder-to-treat population represents more than 40 million people in the US, for which no Omega-3 prescription drug has yet been approved by the US Food and Drug Administration (FDA)," Waksal added.
The study reported a statistically significant HDL increase and reductions in LDL and non-HDL, while efficacy of CaPre increased from four to eight weeks at all doses.
From the patient population of more than 230, who completed the eight week treatment, 88% showed mild to moderate baseline triglycerides between 200 and 500mg/dL.
A mean triglyceride decrease of 15.5% from baseline and an absolute mean improvement of 18.1% were noted in patients treated with 4g of CaPre a day over four weeks, as compared to standard of care.
Increased benefits were noted after the eight-week treatment, with patients on a daily dose of 4g of CaPre, registering a mean triglyceride decrease of 21.6% and an absolute mean improvement of 14.3%, when compared to standard of care.
In standard of care, a significant improvement in triglyceride levels was observed during the trial between four weeks and eight weeks, due to lipid lowering medication adjustment.
A dose response relationship revealing a maintained and improved efficacy of CaPre after an eight-week period was noted after doubling the daily dosage of CaPre from four to eight weeks.
Patients under a daily dose of 4g of CaPre had a mean LDL decrease of 8.3% and non-HDL decrease of 14.3%, while lower doses did not show harmful effect on LDL or non-HDL, after eight-week treatment.
A statistically significant HDL increase of 11.1% between the standard of care and the 4.0g CaPre treatment groups was observed after a four-week treatment period.