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"We are pleased to announce completion of patient dosing in our 48-week
Phase 2b trial, TIME-2b,” said
TIME-2b Study Overview
The TIME-2b study is a double-masked, placebo-controlled, multi-center
trial evaluating the effect of AKB-9778 in 167 patients with moderate to
severe NPDR. Patients were randomized to receive 48 weeks of treatment
with either AKB-9778 15 mg subcutaneously once daily (and placebo
subcutaneously once daily), AKB-9778 15 mg subcutaneously twice daily,
or placebo subcutaneously twice daily. The primary endpoint of the
TIME-2b study is the percentage of patients who improve by 2 or more
steps in diabetic retinopathy severity score (DRSS) in the study eye.
One of the secondary objectives, the urine albumin to creatinine ratio
or UACR, was prospectively included based on a post-hoc analysis
of this biomarker in the TIME-2 Phase 2a clinical trial of AKB-9778.
Initial results from this trial are expected in
AKB-9778 is being developed as a subcutaneous injection for the treatment of non-proliferative diabetic retinopathy. AKB-9778 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. AKB-9778 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.
About Diabetic Retinopathy
Diabetic retinopathy (DR) is a complication of diabetes caused by damage to blood vessels in the retina. DR occurs in roughly one of three patients with diabetes and involves both eyes 75% of these patients. Severity of DR ranges from mild non-proliferative diabetic retinopathy to more advanced proliferative diabetic retinopathy, the hallmark of which is the development of new abnormal blood vessels. DR is the leading cause of blindness among working aged adults around the world, affecting roughly 140 million diabetics globally.
Investor & Media:
Aerpio Pharmaceuticals, Inc.
Chief Financial Officer
Burns McClellan, on behalf of Aerpio Pharmaceuticals, Inc.
Nancie Steinberg / Robert Flamm, Ph.D.
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