Cerenis Therapeutics Inc., a pharmaceutical startup based in Ann Arbor and Toulouse, France, Thursday reported the completion of a Phase I clinical trial for CER-002, one of the company's product canddiates.

The drug -- technically known as a peroxisome proliferator activated receptor delta specific agonist -- shows "broad potential for the treatment of cardiovascular and metabolic diseases," the company said.

In preclinical models, the drug has "demonstrated strong efficacy" in boosting levels of HDL, the so-called good cholesterol, and halting the progression of atherosclerosis, the process of deposition of fat on the inside of arteries.
 

CER-002 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," said Jean-Louis Dasseux, president and CEO of Cerenis. "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.”

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 included 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.

More at www.cerenis.com.