Aerpio Pharmaceuticals, Inc. (NASDAQ:ARPO) Q3 2018 Earnings Conference Call - Final Transcript

Nov 07, 2018 • 08:30 am ET

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Aerpio Pharmaceuticals, Inc. (NASDAQ:ARPO) Q3 2018 Earnings Conference Call - Final Transcript

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Presentation
Operator
Operator

Good morning, ladies and gentlemen. Thank you for standing by and welcome to Aerpio Pharmaceuticals Third Quarter 2018 Financial Results and Business Update Conference Call. As a reminder, this conference call may be recorded.

It is now my pleasure to turn the call over to Mike Rogers, Aerpio's CFO. Please go ahead, sir.

Executive
Mike Rogers

Okay, George. Thank you. Good morning and thank you for joining us for Aerpio's third quarter 2018 earnings call. Joining me on the call today from Aerpio is Steve Hoffman, CEO; Joseph Gardner, President and Founder; Steve Pakola, Chief Medical Officer and Kevin Peters, our Chief Scientific Officer.

This morning Aerpio released financial results for the third quarter ended September 30th, 2018. If you've not received the news release or if you would like to be added to the company's distribution list, you can do so on the IR page of our website at aerpio.com.

(Forward-Looking Cautionary Statements)

I'll now turn the call over to our CEO, Steve Hoffman. Steve?

Executive
Steve Hoffman

Thanks, Mike and good morning, everyone. Thank you for joining us today. We are pleased with the progress Aerpio made in the third quarter as we continued to work towards advancing our pipeline of first-in-class products that activate Tie2 to treat ocular diseases and diabetic complications. As a reminder, the TIME-2b study was designed as a double-masked, placebo-controlled, multi-center trial where 167 patients were randomized to receive 48 weeks of treatment with either AKB-9778, 15 milligrams subcutaneous once daily, AKB-9778, 15 milligrams subcutaneous twice daily or placebo subcutaneously twice daily.

The primary endpoint of the TIME-2b study is the percentage of patients who improved by 2 or more steps in their diabetic retinopathy severity score in the study eye. Secondary objectives of the study include assessment of DRSS improvement in the fellow eye in patients that have bilateral disease, proportion of patients that develop diabetic macular edema and/or proliferative diabetic retinopathy, progression of diabetic retinopathy and improvement in renal function as measured by a change in the urinary albumin to creatinine ratio or UACR from baseline.

We are encouraged by our data from the previous TIME-2 study and recently presented the renal function data obtained from a post-hoc analysis of the TIME-2 Phase II clinical trial of 9778 in diabetic retinopathy patients at the American Society of Nephrology in San Diego. The post-hoc analysis of kidney function that we observed is very compelling and demonstrates the potential of AKB-9778 to become a significant treatment option for patients suffering from diabetic complications, which we believe is consistent with Tie2 activation by 9778. As we've stated previously, if the upcoming results of the TIME-2b study are successful, we expect to initiate the Phase III trial -- trials in NPDR in early 2020.

Moving beyond our program for diabetic retinopathy, we are continuing to evaluate AKB-9778 for additional therapeutic indications. We're looking forward to beginning a Phase Ib study for a topical eyedrop formulation of AKB-9778 in patients with open-angle glaucoma in the second quarter of 2019 and expect to report