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."

“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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.