Benzinga | Dec 11, 2020 05:02PM EST

Aerpio Announces Statistically Significant Topline Results from Razuprotafib Glaucoma Phase 2 Trial

Primary endpoint achieved with twice-daily dose group at 28 day time point versus latanoprost control group.



Patient enrollment and dosing continues in both COVID-19 clinical trials

CINCINNATI, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Aerpio Pharmaceuticals, Inc.(Aerpio) (NASDAQ:ARPO), a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications, as well as other indications in which the Company believes that activation of Tie2 may have therapeutic potential, including acute respiratory distress syndrome ("ARDS") associated with COVID-19 infections, today announced that razuprotafib met the primary efficacy endpoint at Day 28 with the twice-daily ("BID") dose group in Aerpio's double-blind, placebo-controlled Phase 2 trial in patients with elevated intraocular pressure ("IOP") associated with open angle glaucoma ("OAG") or ocular hypertension ("OHT"). The change from baseline in diurnal mean IOP at Day 28 of study eyes treated with razuprotafib BID plus latanoprost showed a statistically significant improvement, or drop in IOP, (two-sided p-value 0.0130 and LS mean difference of -0.92 mm Hg) compared to those treated with latanoprost monotherapy. The razuprotafib once-daily ("QD") dose group did not show a statistically significant improvement at Day 28.

The study was designed to evaluate the safety and efficacy of a topical ocular formulation of razuprotafib as an adjunct to standard of care latanoprost. A total of 194 patients completed a 28-day washout period and were randomized in a 1:1:1 fashion to receive latanoprost ophthalmic solution 0.005% once daily with adjunctive therapy consisting of placebo, 40 mg/ml razuprotafib once-daily, or 40 mg/ml razuprotafib twice-daily. The primary endpoint of the study was mean diurnal IOP at 28 days in the razuprotafib treated groups compared to the latanoprost monotherapy group.

"Tie2 activation with razuprotafib once again was associated with a measurable effect consistent with its mechanism for vessel stabilization, in this case Schlemm's canal, in the front of the eye," stated Joseph Gardner, President and Founder. "We expect to receive the full dataset later in the month and will review the data in more detail as well as our strategic plans with respect to our glaucoma program."

Our two ongoing clinical trials of razuprotafib in COVID-19 patients continue to progress with patient enrollment and dosing. If successful, these trials may open the door to treating ARDS across a broader array of infections. We remain on track to provide additional updates on these Phase 2 clinical trials in the first half of 2021.