MI-CERENIS-THERAPEUTICS

Cerenis Therapeutics, the biopharmaceutical HDL company developing CER-001, an engineered human apoA-I-containing pre-β HDL mimetic for the treatment of cardiovascular disease, today announced the appointment of a new CMO and new Board Members and the leadership of a Phase II clinical CARAT study of CER-001 in post-Acute Coronary Syndrome (ACS) patients.

"We are delighted that such prestigious people have agreed to become new Board members, that Dr. Stephen Nicholls, an international HDL expert, will collaborate with Cerenis and that a highly knowledgeable cardiologist such as Dr. Renee Benghozi has become our new CMO." said Dr. Jean-Louis Dasseux, President and CEO of Cerenis. "The Board members’ medical expertise will be essential in our strategy and Dr. Benghozi’s drug development experience will be key to the critical development stage of CER-001, our lead product in Acute Coronary Syndrome (ACS) and two orphan indications. All these eminent specialists will support the preparation of the future Phase II CARAT clinical study of CER-001 in patients post ACS in order to bring our breakthrough HDL therapy to patients.”

Dr. Stephen Nicholls added: “I’m particularly enthusiastic about collaborating with Cerenis Therapeutics for the future Phase II CARAT clinical study of CER-001. On the basis of our convincing analyses of the Phase II CHI-SQUARE study highlighting the efficacy of the optimal 3mg/kg dose, I’m highly confident regarding the potential success of this important clinical step to establish CER-001 as the market benchmark in HDL mimetics.”

• Appointment of a new CMO:

Dr. Renee Benghozi is an international clinical specialist in the development of pharmaceutical products for the treatment of cardiovascular and metabolic diseases.

• Appointment of a new Board Members:

Mr. Christian Chavy, CEO of Stallergenes, Dr Michael Davidson, internationally recognized expert on atherosclerosis and lipids, and Dr Marc Riviere, General Partner at the Montreal-based TVM Capital Life Science team join the Cerenis Board of Directors as new members.

• Appointment of the Principal Investigator for the future Phase II clinical CARAT study of CER-001:

Dr. Stephen Nicholls has been designated to lead the study as Principle Investigator and Chairman of the Steering Committee for the future Phase II clinical CARAT study of 3g/kg CER-001 in post-Acute Coronary Syndrome (ACS) patients.

In addition to Dr. Stephen Nicholls (Principal Investigator), the following outstanding leaders in the field of atherosclerosis research and IVUS technology will make up the CARAT Steering Committee:

• Dr. John Kastelein , professor of medicine, chairman of the department of vascular medicine, Strategic Chair of Genetics in Cardiovascular Disease at the Academic Medical Center of the University of Amsterdam, Amsterdam, The Netherlands;
• Dr. Béla Merkely , Chairman at Semmelweis University Heart and Vascular Center, Head of the Laboratory of Hemodynamics – Saint George Hospital of the County of Fejér, Budapest, Hungary;
• Dr. Steven Nissen , Chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at Cleveland Clinic’s Sydell and Arnold Miller Family Heart & Vascular Institute, Cleveland, USA;
• Dr. Kausik Ray , Professor of Cardiovascular Disease Prevention in the Division of Cardiovascular Sciences at St George’s Hospital, University of London, Honorary Consultant Cardiologist at St George’s Hospital NHS Trust, London, United Kingdom;
• Dr. Gregory Schwartz, Professor of Medicine Chief, Cardiology Section, at the Veterans Affairs Medical Center, Denver, USA;
• Dr. Stephen Worthley , Head of the Cardiovascular Research Centre at the University of Adelaide and Helpman Professor of Cardiovascular Medicine, Adelaide, Australia.

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About Cerenis Therapeutics: www.cerenis.com

Cerenis Therapeutics is an international biopharmaceutical company dedicated to the discovery and development of innovative HDL therapies for the treatment of cardiovascular and metabolic diseases. Cerenis is developing HDL mimetics for the rapid regression of atherosclerotic plaque in high-risk patients, and drugs that increase HDL in patients with low HDL. Cerenis is well-positioned to become the leader in the HDL therapeutic market, with a broad portfolio of programs being developed.
Since its inception in 2005, the company has been funded by top tier investors: Sofinnova Partners, HealthCap, Alta Partners, EDF Ventures, Daiwa Corporate Investment, TVM Capital, Orbimed, IRDI/IXO Private Equity and Bpifrance (Fund for Strategic Investment).

About CER-001:

CER-001 is an engineered 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. Its mechanism of action is 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.

Contact:

Cerenis Therapeutics
Jean-Louis Dasseux, Tel: +33 (0)5 62 24 09 49
CEO
info@cerenis.com