Aerpio Initiates Phase 1b Clinical Trial of Topical Ocular Formulation of AKB-9778 for Primary Open Angle Glaucoma
June 10 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 dosing
of the first subject in a Phase 1b trial of a topical ocular
formulation of AKB-9778 in development for treatment of primary
open angle glaucoma (POAG).
The Phase 1 study is a double-masked, multiple-ascending dose
trial and will enroll four cohorts of 12 subjects. Subjects will
receive increasing daily doses of a topical ocular formulation of
AKB-9778 or placebo for seven days. The primary endpoint of the
trial is ocular safety and tolerability, with IOP lowering as the
key pharmacodynamic endpoint.
“POAG is characterized by increased IOP leading to optic nerve
and neuroretina anomalies and progressive visual field defects,”
said Kevin Peters, M.D., Chief Scientific Officer of Aerpio
Pharmaceuticals. “Reducing IOP has proven to be the only clinical
approach shown to slow or prevent vision loss. The conventional
outflow pathway, consisting of the trabecular meshwork and a
specialized vessel called Schlemm’s canal, controls IOP and has
been identified as the site of increased resistance to aqueous
humor outflow in POAG. We have recently shown in animal models that
topical ocular dosing of AKB-9778 lowers IOP via its action on
Schlemm’s canal, and in two sequential Phase 2 clinical studies, we
have shown that subcutaneous administration of AKB-9778
significantly reduced IOP in ocular normotensive patients. Bases on
these data, we believe that AKB-9778 could provide a novel and
differentiated approach to treating POAG and the first approach
that directly affects Schlemm’s canal. We look forward to sharing
the results of this study by the end of 2019.”
About AKB-9778
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 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. Tie2 is an
important regulator of vascular stability and its down-regulation
is found in patients with diabetes and other conditions.
Down-regulation is caused by activation of two inhibitors of Tie2,
VE-PTP and Ang-2. The Company’s lead compound, AKB-9778, is being
investigated, in a topical drop formulation, for its potential as a
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/20190610005193/en/
Investor &
Media:Aerpio Pharmaceuticals, Inc.Michael
RogersChief Financial Officermrogers@aerpio.com
or
Burns 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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