Aerpio Therapeutics, a clinical‐stage biopharmaceutical company focused on advancing innovative therapies for the treatment of diabetic eye disease and inflammatory bowel disease, today announced positive data from its Phase 1 trial of AKB-9778 for the treatment of diabetic macular edema (DME). AKB-9778, a first-in-class human protein tyrosine phosphatase beta (HPTPβ) inhibitor, works to activate Tie2, a receptor on vascular endothelial cells that promotes vascular stability, preventing abnormal blood vessel growth and vascular leak. The data show AKB-9778 was well tolerated through the predicted efficacious dose range, supporting the clinical advancement of AKB-9778.
"Considering the pivotal importance of Tie2 activation in the retinal vasculature, we believe AKB-9778 could offer patients with diabetic macular edema a more effective therapy either alone or in combination with current therapies. AKB-9778 also offers the important benefit of being self-administered, which is not possible with currently marketed treatments," said Kevin Peters, MD, Chief Scientific Officer and VP of Research and Development, Aerpio. "We look forward to advancing AKB-9778 in the clinic and expect to start a Phase 1b/2a trial in the second quarter of 2012."
The Phase 1 study was designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of AKB-9778 in healthy volunteers. The trial enrolled 48 healthy volunteers and was conducted at Medpace, Inc. in Cincinnati, OH. AKB-9778 was well tolerated through the predicted efficacious dose range with evidence of on-target pharmacology. Together with preclinical data, these findings support advancing AKB-9778 into a pilot 1b/2a study to explore the safety and efficacy of AKB-9778 in patients with diabetic macular edema.
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