TOULOUSE, France--(BUSINESS WIRE)--Cerenis Therapeutics (FR0012616852-CEREN) today announced that new data for CER-001 were presented at a top symposium on atherosclerosis within the American Heart Association (AHA) Scientific Sessions 2015, held in Orlando, Florida, from November 7-11, 2015.
CER-001 is a novel, engineered HDL-mimetic comprised of recombinant human apoA-I and charged of phospholipids that mimics the beneficial properties of natural nascent HDL, especially the ability to regress atherosclerotic plaques.
Cerenis Therapeutics is an international biopharmaceutical company dedicated to the discovery and development of innovative HDL therapies (“good cholesterol”) for treating cardiovascular and metabolic diseases.
The new data showed that CER-001 at the dose of 3 mg/kg induced atherosclerosis regression as measured by coronary IVUS, in patients with a baseline PAV ≥30%. Investigators reported a statistically significant decrease in PAV vs. placebo. PAV is a marker directly linked to the risk of cardiovascular outcomes.
The data were presented at an AHA oral session by Professor Stephen Nicholls, Director of the prestigious Heart Health Research team at the South Australian Health and Medical Research Institute (SAHMRI) in Adelaide, Australia, and world expert in HDL research through medical imaging. Pr. Nicholls noted that, “these findings identify Acute Coronary Syndrome (ACS) patients with high-risk plaque features are the most likely to benefit from HDL mimetic therapy with CER-001. It also supports the design of the phase II CARAT trial which SAHMRI is leading“.The full publication of these data is now being prepared.
Cerenis recently announced that the first patients had entered the phase II CARAT trial, which uses IVUS to assess reduction in atherosclerotic plaque using CER-001 in post-ACS patients. The CARAT trial is progressing in line with the defined schedule and the results are expected during the 1st quarter of 2017. If CARAT is successful, Cerenis plans to proceed with a pivotal Phase III study.
Dr. Jean-Louis Dasseux, Founder and CEO of Cerenis comments: “These results are key to further understanding the benefits of CER-001 at slowing or reversing the progression of the atherosclerotic plaque as well as identifying in which patients CER-001 would be the most effective. These data also illustrate that it is in line with the preclinical data showing the U-shape dose response and that it is better to have more administrations at a low dose than fewer administrations at a high dose.”