US-based biopharmaceutical company Aerpio Therapeutics has reported positive Phase IIa of Time-2 study results of its AKB-9778 to treat patients with diabetic macular edema (DME).
AKB-9778 is a first-in-class small molecule, which acts as an inhibitor of the enzyme, vascular endothelial protein tyrosine phosphatase (VE-PTP), a negative regulator of the Tie2 receptor.
Blocking the VE-PTP from negatively regulating the Tie2 receptor leads to the restoration of the Tie2 signal, thereby overcoming the vascular destabilisation effects.
The Phase IIa TIME-2 study is a randomised, double-masked, placebo-controlled, proof-of-concept study in DR patients with DME.
The trail included 144 patients randomised equally and was administered to AKB-9778 as monotherapy or in combination with Lucentis compared with Lucentis alone for a treatment period of three months, followed by a two-month observation period.
It focused on the primary endpoint measure, which was a mean change from baseline in central subfield thickness (CST) at three months.
The secondary endpoint measures included visual acuity and safety outcomes.
The combination therapy has also demonstrated improved visual acuity when compared to Lucentis alone.
Aerpio chief medical officer Dr Steve Pakola said: "The TIME-2 study has provided broad mechanistic support for the potential use of AKB-9778 in promoting the stabilisation of vascular beds.
"Based on these promising results, we are continuing our preparations to advance AKB-9778 into late stage clinical studies in DR and DME."
AKB-9778 is being developed to treat DR and DME and is being explored for an extended application in other vascular retinal disorders, including wet age-related macular degeneration (wAMD).