Cerenis Therapeutics, the pharma startup with offices in Toulouse, France and Portage, Tuesday announced the start of a Phase 2 clinical trial of its lead drug candidate, CER-001, in patients with acute coronary syndrome.
CER-001 is an innovative complex of recombinant human ApoA-I, the major structural protein of HDL, the so-called good cholesterol, and phospholipids. It has been designed to mimic the structure and function of natural, nascent HDL, also known as pre-beta HDL, which is believed to be protective against atherosclerosis.
It is hoped that CER-001 will further reduce cardiovascular events in high-risk patients by promoting removal of cholesterol from the walls of blood vessels.
The double-blind, randomized, placebo-controlled, safety and efficacy study will assess the ability of CER-001 to regress coronary atherosclerotic plaque as measured by intravascular ultrasound. The study will include over 500 patients at 50 centers in the US, Canada and Europe, and will evaluate three different dose levels given in six weekly intravenous infusions.
The study is being done in collaboration with the Global Atherothrombotic Investigative Network and the Montreal Heart Institute. Dr. Jean-Claude Tardif, director of the research centre at the Montreal Heart Institute, is serving as the principal investigator.
Said Tardif: “This is the largest IVUS study conducted with a pre-beta HDL mimetic, and represents a potential new treatment paradigm to reduce the burden of atherosclerosis.”
Pre-beta HDL is believed to protect against cardiovascular disease by removing cholesterol and other lipids from tissues including the arterial wall and transporting them to the liver for elimination. The aim for the clinical use of a recombinant ApoA-I HDL mimetic is to stimulate cholesterol removal in a process known as reverse lipid transport.
“Following the excellent safety and tolerability Phase I results with CER-001, this trial will evaluate the efficacy in ACS patients,” said Jean-Louis Dasseux, CEO of Cerenis. “The potential of HDL therapy is well recognized and CER-001, as a first in class pre-beta HDL mimetic, could have great therapeutic value to patients with ACS.”
Cerenis Therapeutics is an international biopharmaceutical company dedicated to the discovery and development of novel HDL therapies for the treatment of cardiovascular and metabolic diseases.
Since its inception in 2005, the company raised €117 million ($162.5 million). Among the investors is Ann Arbor’s EDF Ventures.