Lundbeck 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.
“This project in Friedreich’s ataxia represents Lundbeck’s focus to discover and develop innovative compounds that address unmet needs for patients. Lu AA24493 is an example of compounds with a great potential for addressing a small but very severe disease,” says Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck.
“Furthermore, this project represents an innovative process in obtaining proof of principle as we look for signals related to a biomarker as an early indicator of drug activity”.