08.13.13
Acasti Pharma, a Neptune Technologies & Bioressources Inc.’s subsidiary, has released positive results for its Phase II “randomized, open-label, dose-ranging, multi-center trial” designed to assess the safety and efficacy of its investigational new drug candidate CaPre in the treatment of mild to severe hypertriglyceridemia.
CaPre was found to be safe and effective with significant mean triglyceride reductions above 20% after 8 weeks of treatment with both daily doses of 4g and 2g. Results also confirmed CaPre’s efficacy at all doses, which facilitates dose adjustment for better patient management; in addition to statistically significant HDL increase; and reductions in LDL and non-HDL.
The primary objective of the study was to evaluate the safety and efficacy of CaPreat different doses over a
4-week treatment period in patients with mild to severe hypertriglyceridemia as compared to Standard of Care alone. Standard of Care could be any treatment physicians considered appropriate in a real-life clinical setting and included lifestyle modifications as well as lipid modifying agents, such as statins, ezetimibe and fibrates. Demographics and baseline characteristics of the patient population were balanced in terms of age, race and gender. Over 230 patients completed the 8 weeks treatment, which exceeded the targeted number of evaluable patients. From this patient population, 88% had mild to moderate baseline triglycerides between 200 and 500mg/dL (2.28 to 5.7 mmol/L).
The study met its primary objective showing CaPreto be safe and effective in reducing triglycerides in patients with mild to severe hypertriglyceridemia. After only a 4-week treatment, CaPre achieved a statistically significant triglyceride reduction as compared to Standard of Care. Patients treated with 4g of CaPre a day over 4 weeks reached a mean triglyceride decrease of 15.5% from baseline and an absolute mean improvement of 18.1% as compared to Standard of Care.
Results also showed increased benefits after 8 weeks of 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% as compared to Standard of Care, in which, due to lipid lowering medication adjustment, a significant improvement in triglyceride levels was observed during the trial between 4 weeks and 8 weeks.
No serious adverse events were reported, indicating that CaPreis safe and tolerable at all doses tested. Furthermore, data revealed a positive risk/benefit ratio for CaPre, with patients on CaPreshowing a lower incidence of adverse events compared to the Standard of Care group.
In addition, after doubling the daily dosage of CaPre from 4 to 8 weeks, the results indicate a dose response relationship revealing a maintained and improved efficacy of CaPre after an 8-week period. The efficacy of CaPre at all doses and increased effect with dose escalation suggests that CaPre may be titratable, allowing physicians to adjust dosage in order to better manage patients’ medical needs.
After 8 weeks of treatment, patients under a daily dose of 4g of CaPrehad a mean LDL decrease of 8.3% and non-HDL decrease of 14.3%, while lower doses did not show deleterious effect on LDL or non-HDL. Moreover there was, after a 4 week treatment, a statistically significant HDL increase of 11.1% between the Standard of Care and the 4.0g CaPre treatment groups.
For more information: www.neptunebiotech.com
CaPre was found to be safe and effective with significant mean triglyceride reductions above 20% after 8 weeks of treatment with both daily doses of 4g and 2g. Results also confirmed CaPre’s efficacy at all doses, which facilitates dose adjustment for better patient management; in addition to statistically significant HDL increase; and reductions in LDL and non-HDL.
The primary objective of the study was to evaluate the safety and efficacy of CaPreat different doses over a
4-week treatment period in patients with mild to severe hypertriglyceridemia as compared to Standard of Care alone. Standard of Care could be any treatment physicians considered appropriate in a real-life clinical setting and included lifestyle modifications as well as lipid modifying agents, such as statins, ezetimibe and fibrates. Demographics and baseline characteristics of the patient population were balanced in terms of age, race and gender. Over 230 patients completed the 8 weeks treatment, which exceeded the targeted number of evaluable patients. From this patient population, 88% had mild to moderate baseline triglycerides between 200 and 500mg/dL (2.28 to 5.7 mmol/L).
The study met its primary objective showing CaPreto be safe and effective in reducing triglycerides in patients with mild to severe hypertriglyceridemia. After only a 4-week treatment, CaPre achieved a statistically significant triglyceride reduction as compared to Standard of Care. Patients treated with 4g of CaPre a day over 4 weeks reached a mean triglyceride decrease of 15.5% from baseline and an absolute mean improvement of 18.1% as compared to Standard of Care.
Results also showed increased benefits after 8 weeks of 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% as compared to Standard of Care, in which, due to lipid lowering medication adjustment, a significant improvement in triglyceride levels was observed during the trial between 4 weeks and 8 weeks.
No serious adverse events were reported, indicating that CaPreis safe and tolerable at all doses tested. Furthermore, data revealed a positive risk/benefit ratio for CaPre, with patients on CaPreshowing a lower incidence of adverse events compared to the Standard of Care group.
In addition, after doubling the daily dosage of CaPre from 4 to 8 weeks, the results indicate a dose response relationship revealing a maintained and improved efficacy of CaPre after an 8-week period. The efficacy of CaPre at all doses and increased effect with dose escalation suggests that CaPre may be titratable, allowing physicians to adjust dosage in order to better manage patients’ medical needs.
After 8 weeks of treatment, patients under a daily dose of 4g of CaPrehad a mean LDL decrease of 8.3% and non-HDL decrease of 14.3%, while lower doses did not show deleterious effect on LDL or non-HDL. Moreover there was, after a 4 week treatment, a statistically significant HDL increase of 11.1% between the Standard of Care and the 4.0g CaPre treatment groups.
For more information: www.neptunebiotech.com
