VALBY, Denmark, May 8, 2025 /PRNewswire/ — 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
About amlenetug
Amlenetug is a human monoclonal antibody (mAb) that recognizes and binds to all major forms of extracellular α-synuclein and thereby intended to prevent uptake and inhibit seeding of aggregation.
Amlenetug is being developed by Lundbeck under a joint research and licensing agreement between Lundbeck and Genmab A/S. Amlenetug is an investigational compound that is not approved for marketing by any regulatory authority worldwide.
About the AMULET trial
AMULET trial (NCT05104476) was a phase II, randomized, double-blind, placebo-controlled clinical trial of amlenetug as a potential treatment for patients with MSA. MSA patients were randomized 2:1 to either amlenetug or placebo and treated between 48 to 72 weeks, followed by an ongoing 96 weeks open-label extension period offering all participants to receive treatment with amlenetug.
The primary objective was to evaluate the efficacy of amlenetug on clinical progression in patients with MSA, aiming at showing a slowing in clinical 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 amlenetug on patient’s functioning, disease severity and other aspects of MSA. Amlenetug was delivered as an intravenous infusion every four weeks.
About the MASCOT trial
MASCOT (NCT06706622) is a phase III, interventional, randomized, double-blind, parallel-group, placebo-controlled, optional open-label extension trial that will be conducted in North America, Europe, Asia and Australia.
The trial comprises 2 parts: A double-blind period where participants are randomized to receive either high or low doses of amlenetug, or placebo for 72 weeks, followed by an open-label extension period where all participants enrolled in the trial are offered treatment with amlenetug.
The aim of the trial is to evaluate the efficacy, safety, and tolerability of amlenetug in patients with MSA. Amlenetug will be delivered as an intravenous infusion every four weeks.
Contacts
Marie Petterson
Head of Media Relations, Corp. Communication
[email protected]
+45 29 82 21 82
Jens Høyer
Vice President, Head of Investor Relations
[email protected]
+45 30 83 45 01
Palle Holm Olesen
Vice President, Investor Relations
[email protected]
+45 30 83 24 26
About H. Lundbeck A/S
Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.
Brain disorders affect a large part of the world’s population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments.
As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole.
Lundbeck has approximately 5,700 employees in more than 50 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us via LinkedIn.
References:
1. Foubert-Samier A, et al. Neurobiol Dis. 2020:139:104813
2. Åström DO, et al. Poster Presentation. International MSA Congress 2025
3. Liu M, et al. J Neurol. 2024:14;271(5):2324–2344
4. Yang B, et al. Poster Presentation. International MSA Congress 2025
5. Kjærsgaard L, et al. Poster Presentation. International MSA Congress 2025
CONTACT:
H. Lundbeck A/S
Ottiliavej 9, 2500 Valby, Denmark
+45 3630 1311
[email protected]
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