Aerpio Pharmaceuticals announced that renal function data from the TIME-2 phase 2a study of AKB-9778 in the treatment of patients with diabetic macular edema (DME) were presented at the Keystone Symposium on Reducing the Burden of Diabetes Related End-Organ Injury in Santa Fe, New Mexico.
The company has previously presented data on improvement of diabetic retinopathy after 3 months of AKB-9778 therapy. This presentation provides details from a retrospective analysis of renal function in AKB-9778-treated patients from the TIME-2 study who had a urine albumin/creatinine ratio (UACR) greater than normal at baseline. In this analysis, AKB-9778-treated patients had a 21% decrease (improvement) in UACR at the end of treatment compared to their pre-treatment levels. In addition, 6 of 49 (12%) patients improved to a less severe degree of albuminuria at the end of the study (i.e., macroalbuminuria improving to microalbuminuria or normal, or microalbuminuria to normal).
Kevin Peters, MD, Aerpio’s Chief Scientific Officer, who presented the data, said, “These preliminary results, based on a post-hoc analysis, are consistent with the expected effects of Tie2 activation and suggest a possible role for AKB-9778 to protect the kidney vasculature in patients with diabetes. The study was only three months in duration and we are prospectively following markers of renal function in our on-going 48-week TIME-2b trial of AKB-9778 in diabetic retinopathy.”