DARA BioSciences, Inc. (NASDAQ: DARA), announces the positive results from a successfully completed Phase 1b clinical study for DB959, its peroxisome proliferator activated receptor (PPAR)-delta/gamma agonist, a non-TZD oral drug in development for the treatment of type 2 diabetes. This study's main objectives were to determine the safety and pharmacokinetics of multiple ascending oral doses of DB959Na.
Overall, the safety profile of once daily doses of DB959Na for seven sequential days was comparable to placebo, demonstrating that DB959Na is safe and well-tolerated throughout the 40-fold dose-range tested. Results of steady-state pharmacokinetic measurements indicate that the compound is highly likely to meet the target dosing regimen of once-a-day. Changes in the circulating profile of adiponectin, the established biomarker of PPAR agonism, seen in this study suggests that DB959Na will be pharmacologically active in patients with type 2 diabetes within the well tolerated dose range utilized in this study.
The study was a randomized, placebo-controlled, double-blind, escalating multiple dose clinical trial that enrolled 32 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 2012.
As presented earlier, preclinical results in validated models of human disease demonstrated that DB959 lowered glucose to normal levels, raised HDL, raised the HDL:LDL ratio, and lowered triglycerides. These beneficial effects on glucose and lipids were observed without causing the weight gain which has been seen with other PPAR agonists. The positive lipid effects (e.g., cholesterol and triglycerides) are important because approximately 85% of patients with type 2 diabetes also have lipid abnormalities. Also presented previously were the results of the company's Phase 1a single-ascending-dose study, in which all doses were demonstrated to be safe and well-tolerated. These positive results will allow DB959 to enter Phase 2; DARA has begun planning for a Phase 2a study in patients with type 2 diabetes.
Steve Grossman, MD, Medical Consultant to DARA, said, "The positive safety results over a wide dose range in healthy volunteers and the evidence of pharmacologic activity provides a strong basis for the next phase of development."
Richard A. Franco, CEO of DARA, said, "DARA is meeting its goals and now has two first-in-class drug candidates in clinical trials. DB959 is entering Phase 2 with a positive track record from both preclinical and now Phase 1 clinical studies, while KRN5500 has recently been granted Fast Track Drug status by the US FDA and has recently had the positive results from its Phase 2a study published in the Journal of Pain and Symptom Management."