Aerpio Initiates Phase 1b Clinical Trial of Topical Ocular Formulation of AKB-9778 for Primary Open Angle Glaucoma
- Category: Small Molecules
- Published on Monday, 10 June 2019 16:47
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CINCINNATI, OH, USA I June 10, 2019 I Aerpio Pharmaceuticals, Inc. (Nasdaq: ARPO), a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications, today announced dosing of the first subject in a Phase 1b trial of a topical ocular formulation of AKB-9778 in development for treatment of primary open angle glaucoma (POAG).
The Phase 1 study is a double-masked, multiple-ascending dose trial and will enroll four cohorts of 12 subjects. Subjects will receive increasing daily doses of a topical ocular formulation of AKB-9778 or placebo for seven days. The primary endpoint of the trial is ocular safety and tolerability, with IOP lowering as the key pharmacodynamic endpoint.
“POAG is characterized by increased IOP leading to optic nerve and neuroretina anomalies and progressive visual field defects,” said Kevin Peters, M.D., Chief Scientific Officer of Aerpio Pharmaceuticals. “Reducing IOP has proven to be the only clinical approach shown to slow or prevent vision loss. The conventional outflow pathway, consisting of the trabecular meshwork and a specialized vessel called Schlemm’s canal, controls IOP and has been identified as the site of increased resistance to aqueous humor outflow in POAG. We have recently shown in animal models that topical ocular dosing of AKB-9778 lowers IOP via its action on Schlemm’s canal, and in two sequential Phase 2 clinical studies, we have shown that subcutaneous administration of AKB-9778 significantly reduced IOP in ocular normotensive patients. Bases on these data, we believe that AKB-9778 could provide a novel and differentiated approach to treating POAG and the first approach that directly affects Schlemm’s canal. We look forward to sharing the results of this study by the end of 2019.”
AKB-9778 binds to and inhibits vascular endothelial protein tyrosine phosphatase (VE-PTP), an important negative regulator of Tie2. Decreased Tie2 activity contributes to 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.
About Aerpio Pharmaceuticals
Aerpio Pharmaceuticals, Inc. is a biopharmaceutical company focused on advancing first-in-class compounds that activate Tie2 to treat ocular diseases and complications of diabetes. Tie2 is an important regulator of vascular stability and its down-regulation is found in patients with diabetes and other conditions. Down-regulation is caused by activation of two inhibitors of Tie2, VE-PTP and Ang-2. The Company’s lead compound, AKB-9778, is being investigated, in a topical drop formulation, for its potential as a treatment for open-angle glaucoma. For more information, please visit www.aerpio.com
SOURCE: Aerpio Pharmaceuticals