Glycadia has completed Phase Ia and Phase Ib/IIa clinical trials with its lead compound, GLY-230, and is preparing for additional Phase II trials of GLY-230 in patients with diabetes at risk for diabetic nephropathy and diabetic retinopathy.
Single and multiple rising dose studies in healthy volunteers and in patients with diabetes have shown dose-responsive plasma levels of GLY-230 and no serious adverse events, laboratory abnormalities, or electrocardiographic changes. GLY-230 reduced plasma levels of glycated albumin despite persistent elevation of blood glucose concentrations, and significantly lowered urine protein excretion in patients with diabetes who exhibited increased urine protein (microalbuminuria) at baseline. Patients with diabetes showed increased urine levels of other markers of indicating damage to the kidney filtration barrier that were significantly lowered by GLY-230.
GLY-230 is a first-in-class selective glycation inhibitor and is the first agent in this class to enter human clinical trials.
Glycadia is proceeding with Phase II clinical development of GLY-230 for the indication of diabetic nephropathy in patients with diabetes who have established microalbuminuria, and for the indication of diabetic retinopathy in patients with diabetes who have ophthalmologic changes associated with diabetic retinal disease.