CINCINNATI--(BUSINESS WIRE)--Aerpio Pharmaceuticals, Inc. (OTCQB:ARPO), a biopharmaceutical company focused on advancing first-in-class treatments for ocular diseases, announced today that renal function data from the TIME-2 Phase 2a Study of AKB-9778 in the treatment of patients with diabetic macular edema (DME) was presented at the Keystone Symposium on Reducing the Burden of Diabetes Related End-Organ Injury in Santa Fe, New Mexico.
The company has previously presented data on improvement of diabetic retinopathy after three months of AKB-9778 therapy. This presentation provides details from a retrospective analysis of renal function in AKB-9778-treated patients from the TIME-2 study who had a urine albumin/creatinine ratio (UACR) greater than normal at baseline. In this analysis, AKB-9778-treated patients had a 21% decrease (improvement) in UACR at the end of treatment compared to their pre-treatment levels. In addition, 6 of 49 (12%) patients improved to a less severe degree of albuminuria at the end of the study (i.e., macroalbuminuria improving to microalbuminuria or normal, or microalbuminuria to normal).
Kevin Peters, MD, Aerpio’s Chief Scientific Officer, who presented the data, said, “These preliminary results, based on a post-hoc analysis, are consistent with the expected effects of Tie2 activation and suggest a possible role for AKB-9778 to protect the kidney vasculature in patients with diabetes. The study was only three months in duration and we are prospectively following markers of renal function in our on-going 48-week TIME-2b trial of AKB-9778 in diabetic retinopathy.”
About Aerpio Pharmaceuticals
Aerpio Pharmaceuticals, Inc. is a biopharmaceutical company focused on advancing first-in-class treatments for ocular diseases. The Company’s lead compound, AKB‐9778, is a small molecule activator of the Tie2 pathway and is in clinical development for the treatment of non-proliferative diabetic retinopathy. For more information please visit www.aerpio.com.
AKB-9778 is being developed as a subcutaneous injection for the treatment of non-proliferative diabetic retinopathy. AKB-9778 binds to and inhibits vascular endothelial protein tyrosine phosphatase (VE-PTP), an important negative regulator of Tie2. Decreased Tie2 activity causes vascular instability in many diseases including diabetes. AKB-9778 activates the Tie2 receptor irrespective of extracellular levels of its binding ligands, angiopoietin-1 (agonist) or angiopoietin-2 (antagonist), and may be the most efficient pharmacologic approach to maintain normal Tie2 activation.
Forward Looking Statements
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, the future plans of the Company, the development of the Company’s product candidates and the related clinical studies, including AKB-9778 for non-proliferative diabetic retinopathy or otherwise, and the therapeutic potential of the Company’s product candidates, including AKB-9778. Actual results could differ from those projected in any forward-looking statements due to several risk factors. Such factors include, among others, the ability to raise the additional funding needed to continue to develop AKB-9778 or other product development plans, the inherent uncertainties associated with the FDA and drug development process, competition in the industry in which the Company operates and overall market conditions. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the Company files with the SEC available at www.sec.gov.