Aerpio Pharmaceuticals, Inc. (ARPO) SEC Filing 10-Q Quarterly report for the period ending Wednesday, September 30, 2020

Enrollment completed in the 28-day Phase 2 razuprotafib glaucoma trial; topline data expected to be reported in December 2020 or possibly in early January 2021

Initiated second clinical trial to evaluate razuprotafib for the prevention and treatment of acute respiratory distress syndrome (“ARDS”) in COVID-19 patients and announced first patient dosing in October

First patients dosed with razuprotafib in the I-SPY COVID trial to treat ARDS in critically-ill COVID-19 patients

Ended third quarter 2020 with $47.3 million in cash and cash equivalents

On August 4^th, we announced a second randomized, double-blind Phase 2 clinical trial in patients with moderate-to-severe COVID-19 (“RESCUE” trial). The RESCUE trial is being supported by the U.S. Government operating through the Medical Technology Enterprise Consortium (MTEC). MTEC is a 501(c)3 non-profit organization constructed by the U.S. Army Medical Research and Development Command (USAMRDC). The RESCUE trial is a stand-alone trial managed by Aerpio designed to evaluate patients with moderate-to-severe COVID-19 prior to initiating high flow oxygen or ventilator support. Endpoints will include proportion of subjects alive and respiratory failure-free at Day 28; length of hospitalization from baseline to Day 7; and baseline to Day 28, or death. On October 26^th, Aerpio announced that it had dosed its first patient in this clinical trial. For more details about this clinical trial, please click here.

On September 1^st, Aerpio and Quantum Leap Healthcare Initiative announced dosing of the first razuprotafib patient in the I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with biomarker Integration and Adaptive Learning) to evaluate razuprotafib for the treatment of COVID-19-related ARDS in adult patients with critical COVID-19 (requiring high flow oxygen or ventilator support). The I-SPY COVID Trial is a “platform study” currently planned to evaluate four drug candidates. The goal of the study is to identify agents with the potential to result in substantial improvements to the clinical condition of participants with critical COVID-19. The study is designed to include critical COVID-19 patients who are already intubated or receiving high flow oxygen. For more details about the I-SPY COVID Trial, please click here.

On September 15^th, we announced that we have completed enrollment in the 28-day double-blind, placebo-controlled Phase 2 trial of razuprotafib in elevated intraocular pressure associated with open angle glaucoma (OAG) or ocular hypertension (OHT). The Phase 2 trial is evaluating adjunctive therapy of 40 mg /ml of razuprotafib, administered once, or twice-daily on top of a baseline of latanoprost ophthalmic solution 0.005%. The study enrolled a total of 194 patients.

Our partner Gossamer Bio (Nasdaq: GOSS) indicated that it has initiated its Phase 2 trial of GB004 in ulcerative colitis (NCT04556383). GB004 is an oral, gut-targeted HIF-1 alpha stabilizer that has been shown to improve disease indices in multiple models of inflammatory bowel disease. We out-licensed GB004 to Gossamer through an agreement under which we are eligible for up to a total of $90.0 million in milestone payments related to regulatory approvals and commercial sales. In addition, we are also eligible to receive tiered royalties on sales of licensed products at percentages ranging from the low to mid-single digits as well as 20% of proceeds from any transaction that Gossamer completes that includes the GB004 program.