Cerenis Therapeutics, an international biopharmaceutical company dedicated to the discovery and development of innovative HDL (good cholesterol) therapies for treating cardiovascular and metabolic diseases, announces the dosing of the last patient in the global phase II CARAT study. CARAT is designed to assess the therapeutic efficacy of CER-001, a pre-beta HDL mimetic, in post-acute coronary syndrome (ACS) patients.
Enrollment in CARAT was completed in August 2016 and the last patient has now received the final infusion of CER-001 or placebo. The last patients will undergo intravascular ultrasound (IVUS) imaging of the coronary arteries in the coming weeks and the final follow-up safety visit is expected to occur at the end of the month. Data analysis will commence thereafter and the Company expects to report topline results no later than the first quarter of 2017.
Dr. Jean-Louis Dasseux, founder and CEO of Cerenis, said, “We are delighted to have completed patient dosing and to be nearing the end of the clinical portion of CARAT. Of note, we have reached this stage of the study ahead of schedule. Data collection and analysis will involve imaging of 301 patients who were randomized to either CER-001 or placebo over nine weeks, followed by 30 days of observation, including a follow-up IVUS conducted two weeks after dosing. The design of the CARAT trial and the selection of the optimal dose were based on multiple successful previous studies, and we look forward to announcing topline results no later than the first quarter of 2017.”
Despite secondary prevention measures, the persistent risk of recurrence of a heart attack for patients who have experienced an ACS event remains very high and represents a significant and unmet medical need. By enabling the rapid regression of atherosclerotic plaque, CER-001 could potentially provide an opportunity to reduce the risk of recurrent cardiovascular events during the first few months following an ACS event. Hence CER-001, in addition to long-term LDL-C lowering treatments, could produce further reductions in morbidity and mortality and become the new standard of care for treating patients following an ACS.
CARAT is a double-blind, placebo-controlled, phase II study designed to assess the impact of CER-001 on the regression of atherosclerotic plaque in post-ACS patients by measuring the percent atheroma volume (PAV) using IVUS imaging of the coronary arteries. The primary endpoint is the percentage change from baseline in PAV compared with placebo in a study population with an estimated baseline PAV ≥30% in the target coronary artery.
A total of 301 patients were randomized to either 3mg/kg of CER-001 or placebo in a 1:1 ratio on Day 1 and weekly thereafter for a total of 10 infusions, followed by a 30-day observation period, including a follow-up IVUS two weeks post-dose. The study was conducted at 35 sites in Australia, Hungary, the Netherlands and the U.S. under the supervision of a steering committee.