DARA BioSciences provides additional details of DB959 Phase I study for Type 2 Diabetes

DARA BioSciences, Inc., provided additional details from the recently completed Phase I clinical study for DB959, its PPAR (peroxisome proliferator activated receptor) delta/gamma agonist, an oral drug in development for the treatment of Type 2 Diabetes. As previously announced, the safety of DB959Na was comparable to placebo with no reports of moderate, severe, or serious adverse events in any subjects in the study, and the compound is likely to meet the target dosing regimen of once a day, thus meeting an important goal for the program. New information relates to the additional study objective of determining the maximum tolerated single oral dose of DB959Na. The company announced that subjects in the study tolerated the 200 mg single dose as well as any of the other doses in the study. Therefore, the maximum tolerated single dose is higher than 200 mg, which is well beyond the anticipated therapeutic dose.

The study was a randomized, placebo-controlled, double-blind, escalating single dose study and enrolled 76 healthy male and female volunteers at Quintiles' Phase 1 facility in Overland Park, Kansas. The company plans to present detailed results at an upcoming scientific meeting in the first half of 2011. 

As presented earlier, results of preclinical studies demonstrated that DB959 controlled glucose while raising HDL and the HDL:LDL ratio and lowering triglycerides. These beneficial effects on glucose and lipids were observed without causing the weight gain which is seen with other PPAR agonists. Given the positive results seen in this clinical trial, the company plans to initiate a multiple ascending dose trial in the first half of 2011.