Cerenis Therapeutics SA has announced that it has successfully 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. In the study, the product was found to well tolerated and safe at all doses tested, without any serious adverse effects.
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.
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.