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August 31, 2015 10:48 PM ET


Company Overview of Aerpio Therapeutics, Inc.

Company Overview

Aerpio Therapeutics, Inc., a clinical-stage biopharmaceutical company, engages in the development of therapies for the treatment of diabetic eye disease and inflammatory bowel disease. It offers tie-2 activators and HIF-1 stabilizers. The company was incorporated in 2011 and is based in Cincinnati, Ohio.

9987 Carver Road

Suite 420

Cincinnati, OH 45242

United States

Founded in 2011





Key Executives for Aerpio Therapeutics, Inc.

Chief Executive Officer and Director
Chief Financial Officer and Vice President
Age: 56
Chief Medical Officer
Age: 60
Chief Scientific Officer
Compensation as of Fiscal Year 2015.

Aerpio Therapeutics, Inc. Key Developments

Aerpio Therapeutics Announces Positive Results from its TIME-2 Study of AKB-9778 in DME

Aerpio Therapeutics announced positive results from its TIME-2 study of AKB-9778 in DME. The combination of AKB-9778 (dosed at 15 mg BID) and Lucentis® (ranibizumab injection) provided a clinically significant benefit in reduction of central subfield thickness (CST) compared to Lucentis® alone (p=0.008). In association with this improvement in CST, a positive trend also showed that more patients receiving the combination of AKB-9778 and Lucentis® achieved greater than or equal to three lines of visual acuity compared to Lucentis® alone. The trial additionally included a third treatment arm of patients receiving AKB-9778 alone, dosed at 15 mg BID for 3 months, and this arm did not show a reduction in CST. In regard to the safety profile, there were no clinically significant differences in the percentage of patients that experienced ocular or non-ocular adverse events across the three study arms. Full study results will be presented at an upcoming scientific meeting. The company is also in the process of planning a follow-on clinical study with combination therapy. TIME-2 was a phase 2a, proof-of-concept study meant to validate the biologic signal of efficacy seen in TIME-1. Additionally, TIME-2 sought to establish the safety profile of AKB-9778 in DME. The TIME-2 study evaluated 144 DME patients randomized equally to AKB-9778 as monotherapy or in combination with Lucentis® compared with Lucentis® alone for a treatment period of 3 months. The study’s primary endpoint was mean change from baseline in central subfield thickness. Secondary endpoints included visual acuity and safety outcomes.

Aerpio Therapeutics, Inc. Presents at Needham & Company's 14th Annual Healthcare Conference, Apr-14-2015 10:20 AM

Aerpio Therapeutics, Inc. Presents at Needham & Company's 14th Annual Healthcare Conference, Apr-14-2015 10:20 AM. Venue: Westin Grand Central Hotel, New York, New York, United States. Speakers: Joseph H. Gardner, Chief Executive Officer and Director.

Aerpio Therapeutics Announces Publication of Positive Results of Phase 1b/2a Clinical Trial of Novel Tie2 Activator, AKB-9778

Aerpio Therapeutics, Inc. announced publication of positive results from the company's Phase 1b/2a clinical study of lead clinical candidate, AKB-9778, a Tie2 activator. AKB-9778 is a first-in-class inhibitor of human protein tyrosine phosphatase beta (HPTPβ) that activates the Tie2 pathway to promote vascular stability, preventing abnormal blood vessel growth and vascular leakage. The Phase 1b/2a study, named TIME-1, showed that AKB-9778, administered subcutaneously for 28 days as monotherapy in patients with DME, was well-tolerated and produced clinically meaningful reductions in retinal thickness, correlating with improved visual acuity. The TIME-1 clinical results have been published in an article titled, Treatment of Diabetic Macular Edema with an Inhibitor of Vascular Endothelial-Protein Tyrosine Phosphatase That Activates Tie2. A total of 24 patients with DME participated in the 28-day, open-label, dose-escalation Phase Ib/2a trial. Cohorts of six patients each were treated with 5 mg, 15 mg, 22.5 mg and 30 mg of AKB-9778 delivered subcutaneously BID for 28 days, and patients were observed for an additional 56 days. As previously reported, all dose levels of AKB-9778 were well-tolerated, with no serious adverse events observed. After one month of treatment at doses of 15 mg or greater, 7 out of 18 patients demonstrated a reduction in central subfield thickness (CST) in the study eye of greater than 50µm, and 13 out of 18 patients gained 5 or more letters of visual acuity in the study eye as measured by the best corrected visual acuity (BCVA) assessment.

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