Aerpio initiates clinical trial of AKB-9778 for treatment of PAOG

By Pankaj Singh

A US-based pharmaceutical company, Aerpio Pharmaceuticals, Inc., recently announced the initiation of Phase 1b clinical trial of AKB-9778 to develop treatment of PAOG (primary open angle glaucoma), report sources.

For the record, Aerpio Pharmaceuticals is a biopharmaceutical company that design compounds that activate Tie2 for treatment of ocular diseases & complications of diabetes. Tie2 is a central regulator of vascular stability and in patients with diabetes & other conditions, down-regulation of Tie2 has been observed. The down-regulation is caused by activation of 2 inhibitors of Tie2: Ang-2 and VE-PTP. AKB-9778 is the company’s leading compound and is being investigated in topical ocular formulation to determine its potential in treatment of primary open angle glaucoma.

As per sources close to the matter, the Phase 1 study will enroll 4 cohorts of 12 subjects & the study is a double-masked and multiple-ascending dose trial. The subjects will receive a placebo or increasing daily doses of topical ocular formulation of AKB-9778. The main endpoint of the trial is ocular tolerability & safety, with intraocular pressure lowering as the key pharmacodynamic endpoint.

Kevin Peters, M.D. & Chief Scientific Officer of Aerpio Pharmaceuticals was reportedly quoted saying that primary open angle glaucoma is characterized by increased intraocular pressure (IOP) leading to neuroretina and optic nerve anomalies. The only clinical approach shown to slow down or prevent vision loss is by reducing IOP. The conventional outflow pathway that consists of specialized vessel Schlemm’s canal & a trabecular meshwork, controls intraocular pressure and has been identified as the site of increased resistance to aqueous humor outflow in primary open angle glaucoma.

In a recent study on animal models, it has been observed that suitable ocular dosing of AKB-9778 lowers intraocular pressure, through its action on Schlemm’s canal & in two sequential Phase 2 clinical studies, it has been observed that medical administration of AKB-9778 significantly reduced intraocular pressure in ocular normotensive patients.

Based on the data collected, it can be concluded that AKB-9778 could provide a differentiated approach to treating primary open angle glaucoma. The company is looking forward to sharing the results of this study by the end of 2019, Peters added.

Source credits: http://ir.aerpio.com/phoenix.zhtml?c=254540&p=irol-newsArticle&ID=2401008