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Aerpio begins dosing in trial of diabetic retinopathy treatment

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Patient dosing is underway in the TIME-2b clinical trial of AKB-9778 to treat moderate to severe nonproliferative diabetic retinopathy, according to a press release from Aerpio Pharmaceuticals.

The double-masked, placebo-controlled, multicenter phase 2b trial will include 150 participants with diabetic retinopathy receiving AKB-9778 15 mg subcutaneously once daily, the same drug twice daily or a placebo for 12 months.

“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 [diabetic retinopathy severity score] in both eyes,” Joseph Gardner, Aerpio president and CEO, said in the release.

The study’s primary endpoint is the percentage of participants who improve by at least two steps in diabetic retinopathy severity score in the treated eye, while secondary measures include safety assessment and tolerability of the dosing regimens.