Dara BioSciences said that the study will enroll approximately 75 volunteers and will be conducted at Quintiles’ Overland Park facility. The study’s main objectives are to determine the safety and pharmacokinetics of single ascending oral doses of DB959. The company expects to report the results of the study during the second half of 2010.
The results of preclinical studies demonstrated that DB959 controlled glucose while raising HDL and the HDL:LDL ratio and lowering triglycerides. The beneficial effects on glucose and lipids were observed without causing the weight gain which is seen with other PPAR agonists.
DB959 regulates certain nuclear receptors (peroxisome proliferator-activated receptors, PPARs) that regulate the genes involved in controlling blood sugar levels and certain lipids (e.g. total cholesterol, HDL-cholesterol, triglycerides). The compound acts as an agonist of PPAR delta and PPAR gamma.
Richard Franco, CEO of Dara said: “We are proud of the initiation of this clinical study of DB959, which is now Dara’s second drug candidate to be in clinical development from our pipeline. We are excited about the potential of this compound and that early results have supported our goal of providing patients with a product that offers unique advantages over current approaches to addressing Type 2 Diabetes.
“These advantages include the potential for controlling dyslipidemia and an improved safety profile. We recently reported that our first clinical candidate, KRN5500, successfully completed a Phase IIa study, which demonstrated that KRN5500 was statistically significantly better than placebo in reducing neuropathic pain in patients with cancer.”