H. Lundbeck A/S announced results of the AMULET trial, a phase II, randomized, double-blind, placebo-controlled clinical trial of Lu AF82422 as a potential treatment for patients with Multiple System Atrophy (MSA) (NCT05104476). Signals of efficacy were observed across other clinical and biomarker endpoints, the analysis concluded that there was no statistically significant difference between Lu AF82422 and placebo in the longitudinal changes from baseline in the UMSARS Part I and Part II Total Score after 48 to 72 weeks of treatment. Full trial results are not yet available.

Further prespecified and exploratory analyses of the data set will be conducted to determine the potential of Lu AF82422 in the treatment of MSA, and to define the path of Lu AF82422 development. Lu AF82422 was generally well tolerated. The outcome of the trial is encouraging despite not reaching statistical significance.

will now finalize the analysis of the data and plan the next step for progressing the Lu AF82422 MSA program in dialogue with health authorities. are looking forward to further understand the potential of this program for the benefit of MSA patients. Lundbeck is grateful to all the patients, investigators and caregivers who participated in the trial and contributed to this research.

said Johan Luthman, EVP and Head of R&D, Lundbeck. The trial results are planned to be submitted at scientific conferences and publications at a later date. The AMULET study was a phase II, randomized, double-blind, placebo-controlled clinical trial of Lu AF82422 as a potential treatment for patients with MSA.

A total of N=61 MSA patients were randomized 2:1 to either Lu AF82422 or placebo and treated between 48 to 72 weeks, followed by an ongoing 48 weeks open-label extension period offering all participants to receive treatment with Lu AF82422. The primary objective was to evaluate the efficacy of Lu AF82422 on disease progression in patients with MSA, aiming at showing a slowing in disease progression in the active treatment arm compared to placebo on a 5% significance level evaluated 1-sided as well as safety and tolerability. The secondary objectives included evaluation of Lu AF82422 on patient's functioning, disease severity and other aspects of MSA.

Lu AF82422 was delivered as an intravenous infusion every four weeks. Lu AF82422 is a human monoclonal antibody (mAb) that recognizes and binds to all major forms of extracellular --syn and thereby prevents uptake and inhibits seeding of aggregation. Lu AF82422 has an active Fc region, which may increase immune-mediated clearance of --syn/mAb complexes through microglia mediated uptake.

Lu AF82422 is being developed by Lundbeck under a joint research and licensing agreement between Lundbeck and Genmab A/S.