Lundbeck has expanded its clinical-stage pipeline and initiates the AMULET study, which is designed to confirm the potential of Lu AF82422 as a treatment to slow the rate of disease progression of multiple system atrophy (MSA).
Earlier this year, Lu AF82422 was granted orphan drug designation by the European Medicines Agency (EMA), and the AMULET study has now been approved by the FDA and is ready to enroll the first patient.
Lu AF82422 is a human monoclonal antibody (mAb) targeting the toxic alpha-synuclein protein known to be a pathological hallmark of MSA. The compound is thought to work like the body’s natural immune system to clear these harmful proteins. As it targets the underlying biology of the disease, Lu AF82422 may potentially slow or stop the progression of MSA, states Lundbeck. Lu AF82422 was invented by Lundbeck and Genmab A/S under a collaborative research and license agreement between the two companies.
“We have high expectations for this project and are pleased to advance Lu AF82422 into evaluating its clinical safety, tolerability and efficacy in MSA. Lu AF82422 has the potential to be the first disease-modifying treatment to be approved for the treatment of patients with MSA. Also, we are delighted that the European Medicines Agency acknowledges the urgency to treat this fragile patient population by granting us Orphan Drug Designation. We look forward to learning more about the potential of this unique compound in the innovative AMULET study,” says Johan Luthman, Executive Vice President, Research & Development at Lundbeck.
Photo of Johan Luthman: Lundbeck