[September 02, 2014]

Aerpio Therapeutics Announces Publication of Preclinical Data on AKB-9778 for Common Eye Diseases

Aerpio Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on advancing innovative therapies for vascular diseases, today announced the publication of preclinical data demonstrating that lead candidate, AKB-9778, reduces abnormal blood vessel growth and leakage in mouse models of ophthalmic diseases, such as diabetic macular edema (DME) and age-related macular degeneration. These data were published in collaboration with researchers at Johns Hopkins School of Medicine, Max Planck Institute, and Duke University in the September 2, 2014, issue of The Journal of Clinical Investigation. AKB-9778 is a small molecule activator of Tie2 currently in a Phase 2 clinical study for the treatment of DME.

"The results of the JCI study clearly demonstrate the potential benefit of restoring Tie2 activation in mouse models of major vision-robbing eye diseases. Importantly, the results support the benefit of AKB-9778 as either a monotherapy or as an adjunct to anti-VEGF agents. Taken together, the results strongly support our ongoing development program in patients with diabetic eye disease and the expansion of the program into other major retinal diseases such as wet age related macular edema and retinal vein occlusion," said Kevin Peters, MD, Chief Scientific Officer of Aerpio. "We also showed that AKB-9778 was effective in these models when administered either directly into the eye or when given sytemically by subcutaneous injections. Given the high cost and inconvenience of current therapies for retinal disease, which are typically injected directly into a patient's eye at a physician's office, we sought to develop AKB-9778 as a potential self-administered subcutaneous alternative that could be used as a monotherapy or potentially adjunctively with anti-VEGF agents.

"Our results to date, in both preclinical and early clinical studies, indicate that AKB-9778 is safe and well-tolerated. We have observed a positive effect with AKB-9778 in multiple disease models, as published today. In addition, we have seen highly encouraging signs of clinical activity in patients with DME."

The paper, entitled "Targeting vascular endothelial protein tyrosine phosphatase stabilizes ocular vasculature," was authored by: Jikui Shen, Maike Frye, Bonnie L. Lee, Jessica L. Reinardy, Joseph M. McClung, Kun Ding, Masashi Kojima, Huiming Xia, Christopher Seidel, Raquel Lima e Silva, Aling Dong, Sean F. Hackett, Jiangxia Wang, Brian W. Howard, Dietmar Vestweber, Christopher D. Kontos, Kevin G. Peters, and Peter A. Campochiaro.

About AKB-9778

AKB-9778 is a first-in-class small molecule that works by inhibiting the human protein tyrosine phosphatase ß (HPTPß) enzyme, which acts as a negative regulator of the Tie2 receptor. By inhibiting this enzyme, Tie2 signaling is restored, overcoming the effects of vascular destabilization. Aerpio is currently focusing development of its lead candidate, AKB-9778, in diabetic macular edema (DME), however, Tie2 activators have potential utility in a range of important clinical indications. In the TIME-1 DME study (Phase 1b/2a), AKB-9778 was well tolerated throughout 28 days of dosing, with evidence of disease improvement in some patients. The TIME-2 study (Phase 2), initiated to confirm the efficacy of AKB-9778 alone and in combination with ranibizumab in patients with DME, is currently ongoing.

About Aerpio Therapeutics

Aerpio Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on advancing innovative therapies for vascular diseases. Aerpio is a leader in the development of small molecule drugs based on Tie2 activation and the stabilization of hypoxia-inducible factor 1a (HIF-1a). The Company's lead program, AKB-9778, is a first-in-class stabilizer of the Tie2 pathway and is in clinical development for diabetic macular edema. More information is available at www.aerpio.com.

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