The News

Cerenis Therapeutics completes Phase I clinical trial of CER-022 for treatment of cardiovascular disease

15/05/2008

Toulouse, France, & Ann Arbor, Michigan, May 15, 2008 - Cerenis Therapeutics SA (Cerenis), a privately held pharmaceutical company developing HDL-related compounds for the treatment of cardiovascular and metabolic diseases, today announced that it has completed a Phase I clinical trial for CER-002, one of the company’s lead product candidates. CER-002 is a peroxisome proliferator-activated receptor (PPAR) delta specific agonist in development for the treatment of cardiovascular diseases.

CER-002 is the most advanced small molecule HDL candidate in Cerenis' portfolio. It was developed from new chemical entities that are specific agonists for human PPAR delta, a multifaceted therapeutic target with broad potential for the treatment of cardiovascular and metabolic diseases. In preclinical models, CER-002 has demonstrated strong efficacy in elevating HDL and in halting the progression of atherosclerosis. It was selected for clinical development from a series of small molecule compounds available to Cerenis through a licensing agreement with Nippon Chemiphar Co., Ltd.

"CER-002 is a novel compound which has shown significant antiatherosclerotic properties in animal models even at low doses. The completion of our first clinical trial represents an important milestone for Cerenis, further validating our promising technology platform and our expanding library of investigational compounds to treat atherosclerosis. As we move forward with the clinical development program for CER-002, we will also continue planning clinical stage development programs for the other promising product candidates in our portfolio,” said Jean-Louis Dasseux, Ph.D., M.B.A., president and CEO of Cerenis.

The Phase I study for CER-002 was a randomized, double-blind, placebo-controlled, cross-over, single-rising dose study conducted with healthy male volunteers. Objectives of the study include assessments of the safety, tolerability, and pharmacokinetics of CER-002 when administered as a single dose, as well as the effect of food on single dose pharmacokinetics. Twenty-four subjects received CER-002. The product was found to well tolerated and safe at all doses tested, without any serious adverse effects.

About Cerenis Therapeutics
Cerenis Therapeutics is a pharmaceutical company focused on the discovery, development and commercialization of breakthrough HDL-related therapies for the treatment of cardiovascular and metabolic diseases. Based on pioneering research conducted by the Cerenis team of world leaders in HDL therapy, the company is pursuing a range of HDL product candidates that are positioned to represent major advances in patient care and significant commercial opportunities in the treatment of cardiovascular and metabolic diseases. Cerenis has operations in Ann Arbor, Michigan and Toulouse, France.