Anemias

US-based biopharmaceutical firm Akebia Therapeutics has dosed the first patient in its Phase II clinical trial of AKB-6548 in patients with anaemia related to chronic kidney disease (CKD) undergoing dialysis.

The company is developing AKB-6548 as a once-daily, oral therapy with potential for the treatment of anaemia related to CKD.

Around 60 patients with anaemia related to CKD who are undergoing dialysis, will be enrolled in the multi-centre, open-label Phase II trial and will be given AKB-6548 in place of their existing injectable rESA therapy.

The trial is designed to assess patients for a total of 16 weeks of treatment, including evaluation of haemoglobin (HGB) response to AKB-6548 during an initial eight-week dosing period, followed by an assessment of HGB response to algorithm-guided dose adjustments of AKB-6548 during an additional eight weeks of treatment.

"The company is developing AKB-6548 as a once-daily, oral therapy with potential for the treatment of anaemia related to CKD."

Akebia senior vice-president and chief medical officer Dr Brad Maroni said: "With this study, we are expanding our clinical experience with AKB-6548 beyond the non-dialysis CKD setting to include the treatment of anaemia in patients with end-stage renal disease receiving dialysis.

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"Current therapy with injectable recombinant erythropoiesis-stimulating agents, or rESAs, carries well-documented safety risks and may be associated with excessive increases or fluctuations in haemoglobin levels.

"We look forward to evaluating the potential of AKB-6548 to treat anaemia in patients undergoing dialysis while controlling haemoglobin levels in a safe and predictable manner."

Secondary objectives of the trial include pharmacodynamic response, safety, and tolerability of AKB-6548 in this patient population.

The company intends to submit data from this clinical trial in the third quarter of 2015.

Akebia president and chief executive officer John Butler said: "The initiation of this study is an important milestone in our development programme for AKB-6548.

"We believe AKB-6548 holds best-in-class potential to address the urgent need for safer and more effective treatment options for patients undergoing dialysis who are trying to manage this difficult condition. We look forward to seeing the results of this study next year."

Currently, the company is also assessing AKB-6548 in a Phase IIb trial to treat anaemia related to CKD in non-dialysis patients, with results expected in the fourth quarter of 2014.

The company is focused on the development of new, proprietary therapeutics based on hypoxia-inducible factor (HIF) biology and the commercialisation of these products for patients with kidney disease.

Image: Human blood from a case of iron-deficiency anemia. Photo: courtesy of Dr Graham Beards