Akebia commences dosing in AKB-9778 Phase 1 study for diabetic macular edema and retinopathy

Akebia TherapeuticsNov 21 2011

Akebia Therapeutics, Inc., a small molecule discovery and development company focused on anemia and vascular disorders, today announced that it has dosed the first subjects in a first-in-man Phase 1 study of AKB-9778, a first-in-class human protein tyrosine phosphatase beta (HPTPβ) inhibitor in development for diabetic macular edema (DME) and diabetic retinopathy (DR). AKB-9778 is designed to stabilize vessels in the back of the eye, preventing vascular leak and abnormal blood vessel growth associated with diabetic eye disease.

“Advancing this first-in-class drug candidate into human studies is an important milestone for Akebia”

"Advancing this first-in-class drug candidate into human studies is an important milestone for Akebia," said Kevin Peters, MD, Vice President and Chief Scientific Officer of Akebia. "Based on years of research and data from preclinical studies, we believe that AKB-9778 has the potential to be a major advance for patients with DME and DR. By inhibiting HPTPβ, AKB-9778 in turn activates Tie2, a receptor on vascular endothelial cells that is responsible for stabilizing the vasculature against abnormal blood vessel growth and vascular leak. This combination of activities is ideal to address the two principal causes of vision loss in patients with DME and DR and is backed by data in multiple preclinical models of retinopathy."

The Phase 1 study is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of AKB-9778 in healthy volunteers. In addition, the pharmacology of AKB-9778 will be ascertained by measuring biomarker responses. The trial will involve up to 48 healthy volunteers and is being conducted at Medpace, Inc. in Cincinnati, OH. The study is expected to be completed this year.