Aerpio Pharmaceuticals Announces Completion of Patient Dosing in TIME-2b Study of AKB-9778 in Diabetic Retinopathy
January 17 2019 - 7:00AM
Business Wire
Aerpio Pharmaceuticals, Inc. (Nasdaq: ARPO), a biopharmaceutical
company focused on developing compounds that activate Tie2 to treat
ocular diseases and diabetic complications, today announced the
completion of patient dosing in the Company’s TIME-2b study, a
Phase 2b clinical trial designed to assess the efficacy and safety
of Aerpio’s lead candidate, AKB-9778, for patients with moderate to
severe non-proliferative diabetic retinopathy (NPDR).
"We are pleased to announce completion of patient dosing in our
48-week Phase 2b trial, TIME-2b,” said Stephen Hoffman, M.D.,
Ph.D., Chief Executive Officer of Aerpio. “We now expect to
announce top-line results in March 2019, earlier than our previous
guidance of the second quarter of 2019. AKB-9778 is our
first-in-class, systemically-administered Tie2 activator in
development for the treatment of diabetic retinopathy, as well as
complications of diabetes and other ocular diseases. The data
obtained in our TIME-2 Phase 2a study were very encouraging, not
only in demonstrating improvement in diabetic retinopathy, but also
showing, in a post-hoc analysis, improvement of kidney function. We
believe AKB-9778 has the potential to provide patients with
diabetes a significant treatment option, spanning multiple diabetic
complications."
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 March 2019.
About AKB-9778
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.
About Aerpio Pharmaceuticals
Aerpio Pharmaceuticals, Inc. is a biopharmaceutical company
focused on advancing first-in-class compounds that activate Tie2 to
treat ocular diseases and complications of diabetes. The Company’s
lead compound, AKB-9778, is a systemically-administered small
molecule activator of the Tie2 pathway (via highly selective and
potent deactivation of VE-PTP) and is in clinical development for
the treatment of non-proliferative diabetic retinopathy. AKB-9778
is also being investigated for its potential utility in treating
diabetic nephropathy and an eyedrop formulation is in development
as a potential treatment for open-angle glaucoma. For more
information, please visit www.aerpio.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20190117005089/en/
Investor &
Media:Aerpio Pharmaceuticals, Inc.Michael
RogersChief Financial Officermrogers@aerpio.comorBurns
McClellan, on behalf of Aerpio Pharmaceuticals,
Inc.Media:Nancie Steinberg /
Robert Flamm, Ph.D.nsteinberg@burnsmc.com /
rflamm@burnsmc.comorInvestors:John
Grimaldijgrimaldi@burnsmc.com
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