Aerpio Pharmaceuticals has completed patient enrollment in its phase 2b TIME-2b study of AKB-9778, its treatment candidate for moderate to severe nonproliferative diabetic retinopathy, according to a press release.
The double-masked, placebo-controlled, multicenter trial enrolled 167 patients who will receive 48 weeks of treatment with AKB-9778 15 mg subcutaneously once a day, AKB-9778
15 mg subcutaneously twice a day or placebo subcutaneously twice a day. The trial’s primary endpoint is the percentage of patients who improve by two or more steps in diabetic retinopathy severity score in the study eye.
“We are pleased that the enrollment rate achieved in this trial beat expectations by over 2 months, and we believe this is strong evidence that physicians and their patients recognize the potential advantages of AKB-9778 to potentially treat not only their diabetic retinopathy, but possibly other systemic effects of diabetic microvascular disease,” Steve Pakola, MD, Aerpio’s chief medical officer, said in the release.
Trial data are expected to be available in the second quarter of 2019.