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.