Cerenis Initiates Phase 2 Study of Lead Product Candidate, CER-001, in Patients with Acute Coronary Syndrome

TOULOUSE, France & ANN ARBOR, Mich.--(BUSINESS WIRE)-- Cerenis Therapeutics, a biopharmaceutical company developing novel high-density lipoprotein (HDL) therapies to treat cardiovascular and metabolic diseases, today announced the start of the Phase 2 CHI-SQUARE (Can HDL Infusions Significantly Quicken Atherosclerosis Regression?) study of CER-001 in patients with acute coronary syndrome (ACS).

CER-001 is an innovative complex of recombinant human ApoA-I, the major structural protein of HDL, 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 vessel wall.

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 (IVUS). 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 (GAIN) 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. “We are excited to be conducting the CHI-SQUARE study, which aims to show benefits of CER-001 on atherosclerotic plaque following a short course of therapy.” said Dr. 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.”



About Cerenis Therapeutics
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. HDL is the primary facilitator of the reverse lipid transport, or RLT, pathway by which excess cholesterol is removed from arteries and is transported to the liver for elimination from the body. Cerenis is developing a portfolio of HDL therapies, including HDL mimetics for the rapid regression of atherosclerotic plaque in high-risk patients, and HDL elevators for patients with low HDL. Cerenis is well positioned to become the leader in the HDL therapeutic market with a broad portfolio of programs in development.

Since its inception in 2005, the company raised 117 M€ in equity with top tier investors: Sofinnova Partners, HealthCap, Alta Partners, EDF Ventures, Daiwa Corporate Investment, TVM Capital, Orbimed, IRDI/IXO Private Equity and the FSI (Fund for Strategic Investment). 10,7M€ were also provided by OSEO, the French agency for innovation, to support the development of CER-001.

About CER-001
CER-001, a complex of recombinant human ApoA-I and phospholipids, is being developed for the treatment of patients with acute coronary syndrome. CER-001 is designed to mimic pre-beta HDL, the "good" cholesterol, to promote the removal of excess cholesterol and other lipids from artery walls and enhance reverse lipid transport.


Cerenis Therapeutics
Jean-Louis Dasseux, President and CEO
(for European enquiries, Tel: +33 5 62 24 97 06)
Bill Brinkerhoff, Chief Operating Officer
(for US enquiries, Tel: +1 734 769 1110x217)
College Hill Life Sciences
Melanie Toyne-Sewell / Eileen Paul / Anastasios Koutsos
Tel: +44 20 7457 2020
Rebecca Skye Dietrich
Tel: +1 (857) 241-0795
[email protected]

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