DARA BioSciences, Inc. announced that it has initiated a phase I b 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.
“The promising and exciting results from the phase I a study and the pre-clinical studies prompted us to initiate this clinical study as soon as possible,” said Mary Kay Delmedico, PhD, director of Drug Development and Portfolio Management at DARA. This study's main objectives are to determine the safety and pharmacokinetics of multiple ascending oral doses of DB959Na in both male and female subjects. The Company expects to report the results of the study during Q3 2011.
The results of a phase I a study revealed a promising safety profile, even when dosed at 10X the anticipated human daily dose and a pharmacokinetic profile that supports a once-a-day oral dose. In addition, the 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.
Richard A Franco, CEO of DARA, said, “We are proud of the initiation of this second clinical study of DB959, which is DARA's second drug candidate in clinical development from our pipeline. On the heels of the first successful phase II trial, we plan to initiate a second phase II study for KRN5500 for the treatment of painful chemotherapy induced peripheral neuropathy in patients with cancer during the first half 2011. Advancing two important drug candidates through clinical development for our company is especially gratifying.”
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.
DARA BioSciences, Inc. is a clinical biopharmaceutical development company that acquires promising therapeutic candidates and develops them through proof of concept (pre-phase III) in humans for subsequent sale or out-licensing to larger pharmaceutical companies.