US-based Aerpio Pharmaceuticals has started dosing patients in the Phase IIb (TIME-2b) clinical trial of its product candidate AKB-9778, which could be used to treat patients with non-proliferative diabetic retinopathy.
AKB-9778 is designed to bind to and inhibit the intracellular domain of Tie2’s negative regulator, VE-PTP.
The 12-month trial will assess once-a-day and twice daily 15mg doses of subcutaneous AKB-9778 in 150 patients with moderate to severe non-proliferative diabetic retinopathy.
Aerpio Pharmaceuticals president and CEO Joseph Gardner said: “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 two or more steps in DRSS in both eyes.
“Our goal with AKB-9778 is to treat early diabetic eye disease before the onset of these vision-threatening conditions.”
The trial’s primary endpoint is the percentage of patients showing improvement by a minimum of two steps in diabetic retinopathy severity score (DRSS) in the study eye, while the secondary objectives comprise safety and tolerability of both dosing regimens.
Previously, AKB-9778 demonstrated its ability to activate the Tie2 receptor regardless of extracellular levels of its binding ligands, which include agonist angiopoietin-1 and antagonist angiopoietin-2.
It is expected that the self-administered investigational drug will demonstrate a potential to address diabetic retinopathy in both eyes, while eliminating the necessity for intraocular injections.