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Aerpio Pharmaceuticals says TIME-2b study did not meet primary endpoint.

Aerpio Pharmaceuticals announced top-line results from the company's TIME-2b study, a Phase 2b clinical trial designed to assess the efficacy and safety of Aerpio's lead candidate, AKB-9778, for patients with moderate to severe non-proliferative diabetic retinopathy. Administration of AKB-9778 twice daily did not meet the study's primary endpoint of the percentage of patients with an improvement of two or more steps in the study eye diabetic retinopathy severity score compared to placebo. The percentage of patients achieving this endpoint for AKB-9779 twice daily and placebo were 9.6% and 3.8%, respectively. In all qualified eyes, the percentage of eyes achieving this endpoint was 8.6% and 2.7%, for AKB-9778 BID and placebo, respectively. The rates of progression to sight-threatening complications, including diabetic macular edema and/or proliferative diabetic retinopathy during the 48-week treatment period were similar between treatment groups. AKB-9778 did show encouraging data in a number of prespecified, key secondary endpoints, consistent with the observations in the prior Phase 2a trial, including changes in Urine Albumin-Creatinine Ratio, a measure of kidney function, and in intraocular pressure. The company plans to advance a topical drop formulation of AKB-9778 into clinical development and expects to initiate a Phase 1b study in the second quarter of 2019 with results anticipated by the end of 2019. AKB-9778 was found to be safe and well-tolerated in this patient population through 48 weeks of twice-daily dosing. The most common adverse events with higher incidence in the AKB-9778 BID group were dizziness of 10.9% versus 7.0% in the placebo arm, and headache of 10.9% compared to placebo of 3.5%. There was one death in the study, and it was in the placebo group.

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Publication:The Fly
Date:Mar 18, 2019
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