H. Lundbeck A/S (Lundbeck) will present key pipeline data and patient perspectives from the phase II AMULET trial, investigating amlenetug as a potential new treatment option targeting the rare neurological disorder, multiple system atrophy (MSA), in tandem with recent natural history data, shedding light on early disease progression of the condition.
Lundbeck today announced that pipeline data will be presented at the 2025 International MSA Congress in Boston, U.S., May 9-11. The data includes results from the AMULET phase II trial, coupled with patient perspectives from the trial, and new insights from the MSA natural history study, TALISMAN.
Studying disease progression and survival is essential to understand the natural history of MSA, however currently there is limited data available.1 The TALISMAN study will help to better understand how the disease develops over time, particularly in the early MSA population, and support phase III drug development.2
“MSA is a debilitating disease with a poor prognosis and a significant unmet medical need, however relatively little is known about its progression and natural history, particularly at the early stage. Patient level data like this is important for understanding not only the patients we seek to help, but is critical to guiding our R&D efforts as we move into Phase III trials. We look forward to engaging with the MSA community in May and discussing the impact of this data on future horizons in MSA management,” said Johan Luthman, EVP and Head of Research & Development at Lundbeck.
The data comes as Lundbeck is gearing up for the Phase III trial, MASCOT, involving the investigational treatment, amlenetug, a monoclonal antibody targeting α-synuclein for the potential treatment of MSA. MSA is a rare, rapidly progressing neurodegenerative disease, for which there are currently no approved therapies.3
Lundbeck will also be presenting insights from patients who participated in the completed phase II trial (AMULET).4 These insights highlight the burden of the disease, both for people living with MSA, and also on their care partners. The perspectives from these patient exit-interviews have informed the design of the phase III MASCOT trial, demonstrating Lundbeck’s continued commitment to elevating the patients’ voice in the R&D process, and optimizing clinical trial design around patient needs.
Details of Lundbeck poster presentations at MSA 2025:
Poster 8: Incorporating patient and care partner feedback on the protocol for a clinical trial assessing progression in MSA4
- Presenter: Beatrice Yang, Lundbeck
- Date and location: May 10, 12:00 –13:00 at Porter Square
- Also accepted as oral presentation: May 9, at 13:35 at Amesbury AB
Poster 10: The natural history of multiple system atrophy: a prospective Chinese cohort study2
- Presenter: Aroussi Bidani, Lundbeck
- Date and location: May 9, 11:45 –13:00 at Porter Square
Poster 13: Amlenetug for the treatment of patients with MSA: A randomized, controlled phase 2 trial5
- Presenter: Wolfgang Singer, Mayo Clinic Rochester
- Date and location: May 10, 12:00 –13:00 at Porter Square
- Also accepted as oral presentation: May 9 at 9:55 at Amesbury CD
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