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Aerpio Pharma: TIME-2b Study With AKB-9778 Fails To Meet Primary Endpoint

Aerpio Pharmaceuticals, Inc. (ARPO) announced top-line results from the company's TIME-2b study, a Phase 2b clinical trial designed to assess the efficacy and safety of lead candidate, AKB-9778, for patients with moderate to severe non-proliferative diabetic retinopathy. The company said the 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.

AKB-9778 did show encouraging data in a number of prespecified, key secondary endpoints, consistent with the observations in the prior Phase 2a trial, the company noted. AKB-9778 was found to be safe and well-tolerated in the patient population through 48 weeks of twice-daily dosing.

"While we are disappointed in the primary endpoint results of this study, we are nevertheless encouraged by the fact that several other promising findings observed in our prior 3-month Phase 2a trial have been prospectively confirmed in this 1-year trial. We and our clinical advisors believe that collectively these data support a potentially important role of the Tie2 pathway for the treatment of diabetic complications, as well as for open angle glaucoma. After a full analysis of the study data, we plan to provide an update on the status of the NPDR program," said Stephen Hoffman, CEO of Aerpio.

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