Dara Biosciences, a development-stage pharmaceutical company, has announced that the FDA has cleared the company’s investigational new drug application for DB959, allowing Dara to commence Phase I studies in humans.
DB959 is a unique, first-in-class dual peroxisome proliferator activated receptor delta/gamma agonist and is intended for use in the treatment of type 2 diabetes mellitus including addressing the abnormalities in cholesterol and triglycerides in these patients.
According to the company, the unique combination of the delta/gamma agonist activities gives this therapeutic candidate the potential to provide cardiovascular benefit to type 2 diabetes patients. In non-clinical studies, DB959 has demonstrated the potential to control blood sugar, raise good HDL cholesterol, lower triglycerides, lower total cholesterol and improve the HDL:LDL ratio.
Dara plans to study DB959 as both monotherapy and in combination with other standard glucose lowering agents such as metformin, dipeptidyl-peptidase IV (DPP IV) inhibitors, sulphonylureas (SU), and metformin/SU combinations. DB959 is Dara’s second therapeutic candidate to advance to the clinical trial stage.
Richard Franco, Sr, Dara’s CEO, said: With the current worldwide incidence of type 2 diabetes at around 6% and estimated to increase by 4-5% per year, it is anticipated that by 2030 the diagnosed patient population will be greater than 300 million.
Given that these patients often present with imbalances in cholesterol and triglycerides in addition to elevated blood sugar levels, this milestone, with a candidate drug that has the potential to effectively treat both aspects of the disease is extremely important and exciting and paves the way for the first human clinical trial of DB959.