ANN ARBOR, Mich. and TOULOUSE, France, May 15 CerenisTherapeutics SA (Cerenis), a privately held pharmaceutical company developingHDL-related compounds for the treatment of cardiovascular and metabolicdiseases, today announced that it has completed a Phase I clinical trial forCER-002, one of the company's lead product candidates. CER-002 is a peroxisomeproliferator-activated receptor (PPAR) delta-specific agonist in developmentfor 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 specificagonists for human PPAR delta, a multifaceted therapeutic target with broadpotential for the treatment of cardiovascular and metabolic diseases. Inpreclinical models, CER-002 has demonstrated strong efficacy in elevating HDLand in halting the progression of atherosclerosis. It was selected forclinical development from a series of small molecule compounds available toCerenis through a licensing agreement with Nippon Chemiphar Co., Ltd.
"CER-002 is a novel compound which has shown significantantiatherosclerotic properties in animal models even at low doses. Thecompletion of our first clinical trial represents an important milestone forCerenis, further validating our promising technology platform and ourexpanding library of investigational compounds to treat atherosclerosis. As wemove forward with the clinical development program for CER-002, we will alsocontinue planning clinical stage development programs for the other promisingproduct 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 withhealthy male volunteers. Objectives of the study included assessments of thesafety, tolerability, and pharmacokinetics of CER-002 when administered as asingle dose, as well as the effect of food on single dose pharmacokinetics.Twenty-four subjects received CER-002. The product was found to well toleratedand 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 forthe treatment of cardiovascular and metabolic diseases. Based on pioneeringresearch conducted by the Cerenis team of world leaders in HDL therapy, thecompany is pursuing a range of HDL product candidates that are positioned torepresent major advances in patient care and significant commercialopportunities in the treatment of cardiovascular and metabolic diseases.Cerenis has operations in Ann Arbor, Michigan and Toulouse, France. Forfurther information please visit www.cerenis.com.
SOURCE Cerenis Therapeutics SA