Aerpio Pharmaceuticals announced the initiation 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.
The TIME-2b study is a double-masked, placebo-controlled, multicenter trial that will enroll 150 patients randomized 1:1:1 to receive either AKB-9778 15 mg subcutaneously once daily, AKB-9778 15 mg twice daily, or placebo for a 12-month period. The primary endpoint of the TIME-2b study is the percentage of patients who improve by at least 2 steps in diabetic retinopathy Severity Score (DRSS) in the study eye. Secondary objectives include assessment of safety and tolerability of both dosing regimens.
Victor H. Gonzalez, MD, of Valley Retina Institute (McAllen, TX), who enrolled the first patient in TIME-2b, stated, “TIME-2b is an exciting study because it allows us to evaluate a patient self-administered investigational drug for the treatment of moderate to severe non-proliferative diabetic retinopathy. An early treatment option that potentially improves diabetic retinopathy in both eyes without the need for intraocular injections could completely change our approach to diabetic eye disease.”
More information about the clinical trial is available at: https://clinicaltrials.gov/ct2/show/NCT03197870.
“The start of our TIME-2b study builds upon our clinical proof of concept data, for which we reported that AKB-9778 monotherapy was able to improve underlying diabetic retinopathy by 2 or more steps in DRSS in both eyes,” Joseph Gardner, President & CEO of Aerpio, said in a company news release. “Diabetic retinopathy remains an area of significant unmet medical need. An estimated one out of three individuals with diabetes has retinopathy, which generally progresses over time and can lead to loss of vision due to proliferative diabetic retinopathy or diabetic macular edema. Our goal with AKB-9778 is to treat early diabetic eye disease before the onset of these vision threatening conditions.”