Cerenis Therapeutics Announces Top line Results of CARAT Phase II Study – No statistical difference observed between CER-001 and placebo
TOULOUSE, France and ANN ARBOR, Mich. (March 1st, 2017 at 5.00 pm CET) – Cerenis Therapeutics (Euronext: CEREN ― ISIN: FR0012616852), an international biopharmaceutical company dedicated to the discovery and development of innovative therapies for treating cardiovascular and metabolic diseases, announces results from the global CARAT Phase II study with CER-001 in post-acute coronary syndrome (ACS) patients.
The findings show no statistical difference between CER-001 and placebo in the study’s primary endpoint of percentage change from baseline in percent atheroma volume (PAV) as measured by intravascular ultrasound (IVUS) compared with placebo. The full results will be presented on March 18, 2017 at the Annual American College of Cardiology Scientific Sessions in Washington DC.
CARAT is a double-blind, placebo-controlled study designed to assess the impact of CER-001 on the regression of atherosclerotic plaque in post-ACS patients by measuring PAV using IVUS imaging of the coronary vascular wall. A total of 301 randomized patients were administered 3 mg/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 two-week observation period. The study was conducted at sites in Australia, Hungary, the Netherlands and the United States.
Dr. Jean-Louis Dasseux, founder and CEO of Cerenis, said, “We are surprised and disappointed by the topline findings in the CARAT trial, which are inconsistent with the results of previous studies with CER-001 in this patient population. We will continue to analyze the CARAT data in order to understand these results while also pursuing our other clinical programs. The TANGO Phase III clinical study in patients with a genetic HDL deficiency is ongoing.”
Dr. Dasseux added, “In the near term, we plan to accelerate the development of our other pipeline drugs whose mode of action is different from CER-001. In addition, we will launch a Phase I clinical study for CER- 209 in NASH/NAFLD, two major worldwide health issues, where preclinical results underlie the strong therapeutic potential of this small molecule drug.”
Conference call today, on 1st March, 2017 at 6:00 PM (CET) Jean-Louis Dasseux, founder and CEO of Cerenis Therapeutics will hold a conference call in English on 1st March, 2017 at 6:00 PM (CET). To access this conference call, please dial the applicable number:
From France: 01 70 77 09 41
From UK: +44 – 2033679456
From the United States: +1 6467224908 2
About CER-001 CER-001 is an engineered complex of recombinant human apolipoprotein A-1 (apoA-I), the major structural protein of HDL, and phospholipids, designed to mimic the structure and function of natural, HDL. It is intended to increase apoA-I and the number of HDL particles transiently, to stimulate the removal of excess cholesterol and other lipids from tissues including the arterial wall and to transport them to the liver for elimination through a process called Reverse Lipid Transport.
About Cerenis Therapeutics: www.cerenis.com Cerenis Therapeutics is an international biopharmaceutical company dedicated to the discovery and development of innovative therapies for the treatment of cardiovascular and metabolic diseases. Cerenis is developing a portfolio oftherapies, including HDL mimeticsfor patients with HDL deficiency. Since itsinception in 2005, the company has been funded by top-tier investors including Sofinnova Partners, HealthCap, Alta Partners, EDF Ventures, Daiwa Corporate Investment, TVM Capital, Orbimed, IRDI/IXO Private Equity and Bpifrance. In March 2015 Cerenis completed an IPO on Euronext raising €53.4m.
Source: www:cerenis.com
