Lead candidates include early-clinical stage DME candidate and preclinical-stage drug for IBD.

Akebia Therapeutics has spun out a new company, Aerpio Therapeutics, to continue the development of its small molecule Tie-2 activator and HIF-1α stabilizer programs for multiple diseases. The spin-out’s pipeline includes lead program, AKB-9778, a Tie-2 activator in development for the treatment of diabetic macular edema (DME), which is expected to start in a Phase IIa trial during the first half of 2012. AKB-9778 is designed to inhibit human protein tyrosine phosphatase β, a negative regulator of the Tie-2 receptor, and prevent vascular leak and abnormal blood vessel growth associated with diabetic eye disease. A first-in-man study with the candidate was initiated in November 2011.

Aerpio’s second clinical candidate, AKB-4924, is an HIF-1α stabilizer currently in late preclinical development for the treatment of inflammatory bowel disease (IBD). An IND submission is projected for late 2012. AKB-4924 is designed to stabilize HIF-1α by inhibiting HIF prolyl hydroxylases, and in particular PHD-2.

Akebia’s own lead candidate, AKB-6548, is an orally available hypoxia-inducible factor-prolyl hydroxylase (HIF-PF) inhibitor in development for the treatment of anemia. The drug is designed to increase natural production of erythropoietin, and cause a controlled, gradual rise in hemoglobin levels in anemia patients. A Phase IIa dose-ranging trial evaluating AKB-6548 in stage 3 and 4 chronic kidney disease patients was initiated in June 2011.

Akebia separately confirmed drawing down a $4.1 million tranche of a previously announced $22 million Series B financing to support completion of the Phase II AKB-6548 and progress its search for the optimum partner to move into pivotal Phase III studies.