DARA BioSciences, Inc. is a pharmaceutical 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. Presently DARA has two drug candidates advancing through clinical development and a series of compounds in preclinical development:
1. KRN5500* for the treatment of neuropathic pain in patients with cancer – successfully completed a phase II study. KRN5500 met its primary endpoints of reduction of pain and safety. It was statistically significantly better than placebo (p=0.03). The company plans to initiate a second phase II this year in conjunction with the National Cancer Institute focusing on the treatment and prevention of chemotherapy induced peripheral neuropathy (CIPN). The NCI will sponsor these studies with DARA only having to supply active drug and placebo; and
2. DB959* for the treatment of type 2 diabetes – successfully completed a phase Ia study. DB959 met its primary endpoints of tolerability with a pharmacokinetic profile pointing to a once-a-day oral drug.
In addition, the Company has a pipeline of diverse drug candidates at various stages of development, with 88 US and foreign granted patents and 60 pending applications. The first drug candidate KRN5500 has successfully completed a phase II clinical trial treating neuropathic pain in patients with cancer. KRN5500 met its primary endpoint of reduction of pain from baseline and was statistically significantly (p=0.03) better than placebo. A second phase II clinical trial is planned during the first half of 2011. In addition, DARA has entered into a Clinical Trial Agreement with the National Cancer Institute to study the prevention and treatment of neuropathic pain in cancer patients. The second drug candidate DB959 is an oral, highly selective, non-thiazolidinedione (TZD), first-in-class dual peroxisome proliferator activated receptor delta/gamma agonist in development for type 2 diabetes. A phase Ia clinical study has been completed and the positive results were presented at 71st Scientific Sessions of American Diabetes Association meeting in June 2011. A second phase clinical study is nearing completion and the Company plans to announce results in Q3 2011. In addition, DARA owns a series of compounds in pre-clinical development including CPT-1 inhibitors intended for topical application for patients with psoriasis, a library of DDPIV inhibitors and a diverse library of approximately 1800peroxisome proliferator activated receptor agonists of various molecular modalities. These receptors are found throughout the human body and recent publications report that they may be useful in the treatment of Alzheimer's disease, cystic fibrosis, liver disease, and a variety of autoimmune diseases. Because its diverse peroxisome proliferator activated receptor agonists’ library, it has the potential to address the unmet medical needs of these diseases. The Company plans to explore several of these indications.