Aerpio Therapeutics commences AKB-9778 Phase 1b/2a trial in diabetic macular edema

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.