Aerpio Therapeutics, a clinical-stage biopharmaceutical company
developing innovative therapies for vascular diseases by targeting the
Tie2 pathway, today announced that it has dosed the first patient in a
Phase 1b/2a trial of AKB-9778 for the treatment of diabetic macular
edema (DME). AKB-9778 is a first-in-class human protein tyrosine
phosphatase beta (HPTPβ) inhibitor that works to activate Tie2, a
receptor on vascular endothelial cells which promotes vascular
stability, preventing abnormal blood vessel growth and vascular leak.
"Recent preclinical and clinical data indicate that decreased signaling
through the Tie2 pathway plays an important role in the development of
diabetic retinopathy and possibly other diabetic vascular
co-morbidities, such as nephropathy and neuropathy," said Kevin Peters,
MD, Chief Scientific Officer and VP of Research and Development, Aerpio.
"Based on our preclinical data showing that, through Tie2 activation,
AKB-9778 reduces retinal edema and neovascularization in multiple models
of retinopathy, as well as data from our Phase 1 study earlier this
year, we are optimistic that AKB-9778 could represent an important
advancement in the treatment of DME. We look forward to results of this
study in DME patients in 2013."
The 28-day Phase 1b/2a ascending dose study is designed to evaluate the
safety and efficacy of AKB-9778 in patients with DME. The study will
enroll up to 24 patients at 6 sites throughout the U.S. The primary
endpoint is safety with secondary efficacy endpoints based on decreased
retinal thickness measured by OCT (optical coherence tomography),
improved visual acuity and selected biomarkers.
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