Aerpio Announces Initiation of 28-Day Phase 2 Razuprotafib Glaucoma Trial

CINCINNATI, June 24, 2020 (GLOBE NEWSWIRE) -- Aerpio Pharmaceuticals, Inc. (“Aerpio”) (Nasdaq: ARPO), a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases, ARDS associated with COVID-19, and diabetic complications, today announced that it has commenced patient enrollment in its double-blind, placebo-controlled Phase 2 trial in patients with elevated intraocular pressure (IOP) associated with open angle glaucoma (OAG) or ocular hypertension (OHT). There are now 20 clinical sites actively enrolling patients and 30 patients have been screened and enrolled.

The study is designed to evaluate the safety and efficacy of a topical formulation of razuprotafib in approximately 195 patients followed over a 28-day period. Patients enrolled in the trial will be administered a baseline of latanoprost ophthalmic solution 0.005%, and then randomized in a 1:1:1 fashion to receive adjunctive therapy consisting of placebo, 40 mg/ml razuprotafib once-daily, or 40 mg/ml razuprotafib twice-daily. The primary endpoint of the study will be mean diurnal IOP at 28 days in the razuprotafib treated groups compared to the latanoprost monotherapy group.

“We are extremely pleased by the enthusiasm and productivity of the ophthalmology clinics participating in this trial,” said Kevin Peters, M.D., Chief Scientific Officer and Chief Medical Officer of Aerpio. “We are now likely to have topline data in Q4 2020, in spite of potential slowdowns in clinic visits associated with the COVID-19 pandemic.  We also attribute the rapid pace of patient enrollment to heightened interest from patients and healthcare providers as a result of the differentiated and novel mechanism of action of razuprotafib.”  The Company will provide another update on enrollment during its second quarter earnings call in August.

About Razuprotafib

Razuprotafib 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 and more recently has been shown to contribute to the development of increased IOP and glaucoma. Razuprotafib 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. Aerpio is studying a topical ocular formulation of razuprotafib in open angle glaucoma and exploring the utility of subcutaneous razuprotafib for diabetic complications, including diabetic nephropathy.