E Akebia Therapeutics: A Trade Opportunity With A Catalyst Ahead?

Anemia is common among patients with Chronic Kidney Disease (CKD) and end stage renal disease (ESRD). It is estimated that about 1.8 million people in the U.S. have anemia associated with chronic kidney disease.

Patients with kidney illness have a low supply of erythropoietin (EPO), one sort of hormone created by the kidneys to flag the generation of red blood cells. Again, the production of erythropoietin is regulated by a sort of protein, namely the Hypoxia-Inducible Factor (or HIF).

Akebia Therapeutics Inc (NASDAQ: AKBA) is a biopharmaceutical company focused on the development of noble proprietary therapeutics based on hypoxia inducible factor biology for patients with kidney disease.

They have a drug candidate in focus: AKB-6548, an orally bio-available hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor designed to increase natural production of erythropoietin in chronic kidney disease patients.

Since the levels of hypoxia-inducible variables in body tissues are directed by HIF-PH enzymes, by repressing the HIF-PH enzymes, HIFs could be balanced out or up-regulated, permitting the body to better react to reduced oxygen, injury and infection.

AKB-6548 is under a phase IIb trial in patients with anemia secondary to chronic kidney disease who are not dependent on dialysis. This study was launched in July 2013, and enrollment was finished – reaching the target of 209 patients – in April of this year.

Akebia hopes to proclaim results from the phase IIb study AKB-6548 for the treatment of anemia associated with chronic kidney disease in patients who are not dependent on dialysis sometime during this quarter (Q42014).

A phase II study of AKB-6548 in patients with anemia related to chronic kidney disease undergoing dialysis has also been initiated by the company. Data from this clinical study are expected in the third quarter of 2015.

ESAs (erythropoiesis stimulating agents), which are synthetic versions of EPO, are the mainstay of treatment to correct anemia in chronic kidney disease and end stage renal disease patients. Akebia fosters the hope that AKB-6548 would have a number of advantages over the current standard of care, ESA injections. 

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