Aerpio Pharmaceuticals announced the completion of patient enrollment 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 non-proliferative diabetic retinopathy.
The TIME-2b study is a double-masked, placebo-controlled, multicenter trial that has enrolled 167 patients randomized to receive 48-weeks of treatment with either AKB-9778 15 mg 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. Secondary objectives include assessment of DRSS improvement in the fellow eye in patients with bilateral disease, proportion of patients that develop diabetic macular edema and/or proliferative diabetic retinopathy, and improvement in renal function. More information about the clinical trial is available at: https://clinicaltrials.gov/ct2/show/NCT03197870.
“AKB-9778 is a drug candidate with tremendous potential,” Victor H. Gonzalez, MD, of Valley Retina Institute (McAllen, TX), who enrolled the first patient in TIME-2b, said in a company news release. “Enrolling 167 patients into this trial in just over 7 months speaks to the need for earlier treatment of diabetic eye disease, as well as the need for an alternative to repeated intravitreal injections.”
“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,” commented Aerpio’s Chief Medical Officer, Steve Pakola, MD. “We look forward to the data which will be available in the second quarter of 2019.”