OPKO -Model OPK88003 -Oxyntomodulin Analog
Oxyntomodulin is a naturally occurring hormone produced in the colon, shown to bind both the GLP-1 and glucagon receptor, regulating both blood glucose appetite and lipid metabolism. OPKO Health is developing OPK88003, a long-acting, once weekly oxyntomodulin analog for the treatment of type 2 diabetes and obesity.
Therapeutic Area
Endocrinology
Indication
Obesity and Diabetes
Clinical Trial Status
Phase 3 Ready
OPK88003 (Oxyntomodulin), a once weekly administered peptide for the treatment of type 2 diabetes and associated obesity, is a dual agonist of the GLP-1 (glucagon-l-ike peptide-1) and glucagon receptors. The receptors play an integral role in regulating appetite, food intake, satiety, lipid metabolism and energy utilization in the body. Stimulating both of the receptors, OPK88003 has the potential to regulate both food intake and blood glucose.
OPK88003 has been studied in a Phase 2 clinical trial enrolling 420 type 2 diabetes patients. Subjects receiving the highest dose of OPK88003 (Oxyntomodulin) once weekly demonstrated statistically significant weight loss compared with currently approved long-acting exenatide. OPK88003 also provided a reduction in glycosylated hemoglobin (HbA1c or A1c), a marker of sugar metabolism, similar to exenatide. OPKO Health initiated a Phase 2b dose-escalation clinical trial study for OPK88003 to optimize a dosing regimen that will increase weight loss and reduce HbA1c in diabetes patients in March 2018, this study was completed in 2019. This recent dosing regimen study showed improved weight loss (5.4 Kg), HbA1c (1.4) and lipid profile vs metformin. A more prominent decrease in triglycerides and total cholesterol was observed with OPK-88003 treatment compared to the GLP-1 incretin therapy in a previous phase 2 study.