Aerpio Pharmaceuticals announced the completion of patient dosing in the company’s TIME-2b study, a phase 2b clinical trial designed to assess the efficacy and safety of Aerpio’s lead candidate, AKB-9778, for patients with moderate to severe nonproliferative diabetic retinopathy (NPDR).
“We are pleased to announce completion of patient dosing in our 48-week phase 2b trial, TIME-2b,” Stephen Hoffman, MD, PhD, Chief Executive Officer of Aerpio, said in a company news release. “We now expect to announce topline results in March 2019, earlier than our previous guidance of the second quarter of 2019. AKB-9778 is our first-in-class, systemically-administered Tie2 activator in development for the treatment of diabetic retinopathy, as well as complications of diabetes and other ocular diseases. The data obtained in our TIME-2 Phase 2a study were very encouraging, not only in demonstrating improvement in diabetic retinopathy, but also showing, in a post-hoc analysis, improvement of kidney function. We believe AKB-9778 has the potential to provide patients with diabetes a significant treatment option, spanning multiple diabetic complications.”
TIME-2b Study Overview
The TIME-2b study is a double-masked, placebo-controlled, multicenter trial evaluating the effect of AKB-9778 in 167 patients with moderate to severe NPDR. Patients were randomized to receive 48 weeks of treatment with either AKB-9778 15 mg subcutaneously once daily (and placebo subcutaneously once daily), AKB-9778 15 mg subcutaneously twice daily, or placebo subcutaneously twice daily. The primary endpoint of the TIME-2b study is the percentage of patients who improve by 2 or more steps in diabetic retinopathy severity score (DRSS) in the study eye. One of the secondary objectives, the urine albumin to creatinine ratio or UACR, was prospectively included based on a post-hoc analysis of this biomarker in the TIME-2 Phase 2a clinical trial of AKB-9778. Initial results from this trial are expected in March 2019.