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Lundbeck to Showcase Innovative MASCOT Trial for MSA Treatment

H. Lundbeck A/S, a leader in neuroscience, has announced its plans to present the design of the Phase 3 MASCOT trial at the International Congress of Parkinson's Disease and Movement Disorders® in Honolulu, Hawaii on October 5-9, 2025. This pivotal study focuses on amlenetug, Lundbeck’s investigational monoclonal antibody, targeting Multiple System Atrophy (MSA), a progressive neurodegenerative disease for which there are currently no approved treatments.

Understanding Multiple System Atrophy (MSA)

MSA is characterized by its rapid progression and severe impact on the nervous system, typically becoming symptomatic between ages 55 and 60. Patients face a debilitating disease course, often leading to significant loss of autonomy and requiring extensive care within six to nine years of symptom onset. The pathological hallmark of MSA is the accumulation of the protein α-synuclein, which disrupts brain functions governing movement and balance.

Currently, MSA poses a huge unmet medical need, as the lack of effective treatments leaves both patients and families desperate for viable options. Lundbeck’s amlenetug aims to bridge this gap by potentially slowing disease progression.

Highlighting the MASCOT Trial Design

During the congress, Lundbeck will provide insights into the trial's innovative design, which utilizes Bayesian progression modeling methods. Such methodologies are vital for rare diseases like MSA, where traditional data may be limited. Johan Luthman, EVP and Head of Research and Development at Lundbeck, stated, "The MASCOT trial has been crafted to track the impact of amlenetug on disease progression effectively. By employing innovative methodologies and adaptive elements, we're hopeful this trial will bring about meaningful changes for MSA patients."

The MASCOT trial will enroll participants from various regions, including the EU, US, and Japan. It consists of two main components; first, a double-blind phase where patients will receive either high, low doses of amlenetug, or a placebo, spanning 72 weeks. Following this, an open-label extension phase will ensure all participants have access to treatment.

This approach emphasizes continuous assessment throughout the trial, contrasting with conventional designs that may rely solely on fixed-time points. This holistic data collection aims to yield better insights into amlenetug’s potential to impact MSA progression significantly.

Patient Perspectives and Collaborative Insights

In addition to the trial design, Lundbeck plans to share valuable insights gathered from patients and caregivers who participated in the earlier Phase 2 AMULET trial. These stories offer firsthand accounts of the burdens associated with MSA, enhancing understanding of the disease and influencing the MASCOT trial design.

Presentations scheduled at the congress include:

• - Exploring MSA: How patient insights shape treatment pathways.
• - A randomized trial of amlenetug versus placebo in MSA patients: – The MASCOT study.
• - Disease progression in MSA: Development of the Bayesian Progression Model.
• - Incorporating feedback from patients and caregivers into trial protocols.

The Future of MSA Treatment

As Lundbeck approaches the congress, they emphasize their commitment to addressing the critical needs of MSA and the innovative strides they're making towards finding a viable treatment. While the therapeutic landscape for MSA is largely vacant, the pursuit of amlenetug as a first-in-class therapy reflects Lundbeck’s dedication to improving brain health and reshaping outcomes for patients whose lives have been challenged by this debilitating disease.

For more information or to stay updated on Lundbeck’s developments, visit their corporate website and follow them on LinkedIn. As advancements in neuroscience continue, the voices of patients and families remain central to paving the way for innovative therapies.