The News

Cerenis Reports Positive Results for Phase 1 Study of CER-001, an HDL mimetic, for the Treatment of Cardiovascular Disease

18/05/2010

TOULOUSE, France and ANN ARBOR, Michigan, May 18, 2010. Cerenis Therapeutics, a biopharmaceutical company focused on discovering and developing novel HDL therapies, today announced the completion of a Phase 1 study of the Company's CER-001 investigational product candidate to treat patients with acute coronary syndromes. Results of the completed study provide evidence that the investigational therapy was safe and well-tolerated at all dose levels evaluated, including those intended for future clinical development.

The Phase 1 randomized, double-blind, placebo-controlled, cross-over, single rising dose study of 32 healthy dyslipidemic human volunteers, was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single intravenous infusions of CER-001. In this study, each subject received dosages up to 45 mg/kg and placebo in a two period crossover design. No drug related adverse events were reported for CER-001, and cholesterol mobilization was observed at dose levels of 2mg/kg and higher.

The results from this study were consistent with pre-clinical findings in demonstrating evidence of dose-related cholesterol mobilization, as well as evidence of substantial increases in HDLcholesterol levels. Because of these properties, we believe that administration of CER-001 may promote reverse cholesterol transport and stimulate cholesterol removal in patients.

“These positive results represent an important milestone for the CER-001 program and Cerenis’ approach to developing potent HDL mimetics.” said Jean-Louis Dasseux, CEO of Cerenis. “The data are strongly supportive of continued clinical development of CER-001 as a treatment for patients with high-risk atherosclerosis, including acute coronary syndromes.”

NOTES TO EDITORS

About Cerenis
Cerenis Therapeutics is a multinational 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 are 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.

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

For further information, please contact:
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 1110 x217)
College Hill Life Sciences
Melanie Toyne-Sewell
Adam Michael
Tel: +44 20 7457 2020
cerenis@collegehill.com