As previously announced, the TRIFECTA trial's primary endpoint was met, with patients on 1 gram or 2 grams of CaPre achieving a statistically significant mean placebo-adjusted decrease in triglycerides from baseline. In addition, benefits in other key cholesterol markers were announced, including slight increases in HDL-C (good cholesterol), no deleterious effect on LDL-C (bad cholesterol) and no safety concerns.
With full data, Acasti is now able to meet with the U.S. Food and Drug Administration (FDA) to discuss next steps in the clinical development of CaPre. The meeting is expected to take place in the Corporation's first quarter, ending May 31, 2015.
"With the encouraging results announced to date, we are well positioned to move forward with our clinical program, including a pivotal Phase III trial for CaPre in patients with severe hypertriglyceridemia," said Pierre Lemieux, PhD, Acasti's chief operating officer. "In anticipation that we will eventually receive approval to conduct a Phase III trial, we are ramping up production of CaPre clinical material, using current Good Manufacturing Practices, to ensure a quality product in sufficient quantities is available. This will allow us to avoid any delays due to inventory shortages."