Hanmi Pharmaceutical announced on the 30th that it applied to the Ministry of Food and Drug Safety for approval of an investigational new drug (IND) plan for a phase 3 clinical trial in Korea of "HM11260C (development code)," which is being developed as a blood sugar control treatment for diabetes patients.
HM11260C is a GLP-1 receptor agonist that mimics the effect of glucagon-like peptide-1 (GLP-1), a hormone secreted in the small intestine after meals, to produce blood sugar control and weight loss effects. GLP-1 promotes insulin secretion from the pancreas to lower blood sugar and suppresses glucagon, which raises blood sugar.
The company said the phase 3 trial aims to demonstrate superior blood sugar control versus placebo when HM11260C is administered in combination to patients with type 2 diabetes who are not controlled on the blood sugar control drugs metformin and dapagliflozin, and to compare its safety. Type 2 diabetes develops when insulin is secreted but its function is impaired.
The company added, "Statistically, the probability that an investigational drug will ultimately receive marketing approval is known to be about 10 percent," and noted, "Results that do not meet expectations may emerge during clinical trials and the marketing authorization process, and accordingly there is a possibility that we may change or abandon our commercialization plans."