February 11, 2016
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AKB-9778 improves underlying diabetic retinopathy in TIME-2 study

AKB-9778 alone or in combination with ranibizumab improved underlying diabetic retinopathy in eyes with and without diabetic macular edema in the TIME-2 phase 2a study, Aerpio Therapeutics announced in a press release.

Patients in the TIME-2 study were administered 15 mg of AKB-9778 alone, 15 mg of AKB-9778 in combination with 0.3 mg of Lucentis (ranibizumab, Genentech) or 0.3 mg of ranibizumab alone.

At 3 months, both AKB-9778 study groups had an improvement in underlying retinopathy according to pre-specified analysis by two or more steps on the diabetic retinopathy severity scale.

Rates of two-step improvement were 10% in the AKB-9778 monotherapy arm, 11.4% in the combination arm and 8.8% in the ranibizumab arm, the release said.

In addition, in 11.4% of patients who received AKB-9778, the fellow eye had a two-step or greater improvement compared with 4.2% of patients who received ranibizumab alone.

“Based on this progress, we are continuing our dialogue with advisors and global regulatory agencies to rapidly design and implement the follow-on studies in diabetic retinopathy,” Steve Pakola, MD, chief medical officer of Aerpio, said in the release.