Lundbeck starts clinical phase IIa with Lu AA24493 (cEPO) in Friedreich's ataxia

03-Nov-2009 - Denmark

H. Lundbeck A/S strengthens its pipeline of pharmaceuticals in clinical development by initiating phase IIa clinical studies with the innovative project Lu AA24493 in order to evaluate safety and tolerability and to explore theoretical efficacy parameters of the drug in humans. Lundbeck expects to enrol 35-40 people suffering from Friedreich's ataxia in this study.

Lu AA24493 is a novel carbamoylated form of human erythropoietin (EPO) - a modification of EPO that results in loss of haematopoietic effects but maintains the tissue protective effect. These tissue protective effects translate to very positive effects in a number of animal models for neuronal damage

The primary objective of the study is to evaluate the safety and tolerability of two weeks treatment with a fixed dose Lu AA24493 in patients with Friedreich's ataxia. However, this placebo-controlled programme may also potentially provide efficacy signals via biomarkers.

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