Lundbeck to showcase progress across its movement disorders pipeline with data in multiple system atrophy and Parkinson’s disease at MDS® 2026

• Late-breaking Phase III MASCOT oral presentation will characterize the clinical profile and diversity of participants in Lundbeck’s ongoing global Phase III trial investigating amlenetug in multiple system atrophy (MSA)
• New research across clinical trial endpoints, biomarkers, diagnostic tools and healthcare burden underscores Lundbeck’s expanding scientific program in MSA
• Exploratory Phase Ib data for Lu AF28996 investigating difficult-to-treat motor complications in people with advanced Parkinson's disease

Valby, Denmark, 2 October 2026 – H. Lundbeck A/S (Lundbeck) today announced that data from its movement disorders pipeline will be presented at the International Congress of Parkinson’s disease and Movement Disorders® (MDS) 2026, taking place in Seoul, South Korea (4-8 October).

The presentations span MSA, a rare and rapidly progressing neurodegenerative disease, and advanced Parkinson’s disease (PD), where motor complications remain difficult to control despite optimized treatment. Together, the data reflect Lundbeck’s growing scientific focus in movement disorders and its commitment to advancing innovation in areas where significant unmet need remains.

A key highlight will be a late-breaking oral presentation describing the baseline characteristics of participants enrolled in MASCOT (NCT06706622), the ongoing Phase III trial of amlenetug in MSA. MASCOT enrolled 401 participants with clinically probable or clinically established MSA, including people with both MSA-C and MSA-P, representing a broad spectrum of people living with the disease. The trial is evaluating the safety and efficacy of amlenetug versus placebo over a 72-week double-blind treatment period, with results expected in Q3 2027.

“Movement disorders such as MSA and Parkinson’s disease remain among the most complex and high-need areas in neuroscience,” said Tarek Samad, Executive Vice President and Head of Research & Development at Lundbeck. “The breadth of research we are presenting at MDS reflects our commitment to advancing potential new medicines while strengthening the scientific understanding of the biomarkers and clinical tools needed to support progress for patients.”

Lundbeck will present additional research addressing important challenges in MSA clinical development. These include analyses supporting the use of the modified Unified Multiple System Atrophy Rating Scale Part I, or mUMSARS Part I, as a clinical trial endpoint designed to measure functional decline in people with MSA; validation of the Chinese version of UMSARS for use in clinical trials; and research into cerebrospinal fluid biomarkers that may support disease detection, differential diagnosis and monitoring.

The MSA program also includes new data highlighting the broader burden of MSA. A US observational database study found significantly higher healthcare costs and healthcare resource utilization among people with MSA compared with people with Parkinson’s disease, underscoring the intensive care requirements associated with this rapidly progressing disease.

Exploratory clinical data in advanced Parkinson’s disease
Lundbeck will also present new Phase Ib data for Lu AF28996, an investigational, novel, oral D1-like/D2-like dopamine receptor agonist being developed for people with advanced Parkinson’s disease experiencing motor complications.

The 18-week open-label Phase Ib trial evaluated safety, tolerability and clinical effects in people with inadequately controlled advanced PD experiencing motor fluctuations, with or without dyskinesia (involuntary movements).

The clinical findings will be complemented by preclinical data exploring the relationship between dose, motor efficacy and dyskinesia in a primate model of Parkinson’s disease (MPTP-macaque).

Lu AF28996 and amlenetug are investigational compounds and have not been approved for use by any regulatory authority. Their efficacy and safety have not been established.

Lundbeck’s scientific program at MDS:

About Multiple System Atrophy (MSA)
MSA is a rapidly progressing rare condition that causes damage to nerve cells in the brain. In a person with MSA, an abnormal build-up of the protein α-synuclein is thought to be responsible for damaging the areas of the brain that control balance, movement, and the body's normal functions.¹ MSA is seriously debilitating and places a high disease burden on patients. There is currently no cure for MSA and no available treatment to slow its clinical progression.²

Symptoms of MSA usually start between 55 and 60 years of age, and the typical time to death is 8.6 years after symptom onset.² Although there are many different possible symptoms of MSA, not everyone who is affected will experience all of them. The symptoms of MSA are wide-ranging and include muscle control problems, similar to those of Parkinson's disease.² Many different functions of the body can be affected, and symptoms including urinary incontinence, frequent falling, and unintelligible speech occur within 3 years of disease onset. MSA is accompanied by reduced capacity to live independently, and death is often due to respiratory problems.

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.
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.³

The trial comprises two 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 is delivered as an intravenous infusion every four weeks.

About Parkinson’s disease
Parkinson’s disease is a progressive and disabling neurological disease characterized by motor symptoms including slowness of movement, tremor and rigidity, as well as a range of non-motor symptoms.^4,5

There are currently no established treatments that modify the progression of PD, and levodopa remains a cornerstone of symptomatic treatment.⁶ With long-term levodopa treatment, many people develop motor complications, including periods when symptoms return or worsen (“OFF-time”) and dyskinesia (involuntary movements), which can significantly affect daily functioning and quality of life.^4-7

PD is the second most common neurodegenerative disease after Alzheimer’s disease and the most common movement disorder.^7-8 In 2021, an estimated 11.77 million people worldwide were living with PD, and its prevalence is projected to more than double by 2050.⁹ As PD progresses, functional independence can decline and reliance on caregivers and healthcare systems can increase, contributing to a substantial personal, societal and economic burden.

About Lu AF28996 
Lu AF28996 is an investigational, novel and oral prodrug of a D₁-like/D₂-like dopamine receptor agonist, with a pharmacologic profile that may enhance dopaminergic striatal signaling in a prolonged manner. It is being investigated for its potential to improve motor fluctuations and levodopa-induced dyskinesia in people with Parkinson’s disease. Concerted activation of D1- and D2-like dopamine receptors may play an important role in motor control.

Lu AF28996 is currently in Phase II clinical development. The DARE2 trial (NCT07514858) is evaluating its efficacy, safety and tolerability in adults with Parkinson’s disease experiencing motor fluctuations despite optimized non-invasive symptomatic treatment.¹⁰

Contacts

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 more than 5,000 employees in more than 20 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. Jellinger KA. J Alzheimers Dis. 2018;62:1141–79
2. Palma JA, et al. Auton Neurosci. 2018;211:15–25
3. https://clinicaltrials.gov/study/NCT06706622?intr=Lu%20AF82422&rank=2
4. Stocchi F, et al. Nat Rev Neurol 2024;20:695–707
5. Heim B and Poewe W. J Parkinsons Dis 2025;23
6. Cenci MA. Front Neurol 2014;5:242
7. Kalia LV, Lang AE. Parkinson's disease. Lancet 2015;386:896–912
8. GBD. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol 2017;16:877–897
9. Luo Y, et al. Front Aging Neurosci 2025;16:1498756.
10. https://clinicaltrials.gov/study/NCT07514858?term=nct07514858%20&viewType=Card&rank=1
     

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Denmark

+45 3630 1311

info@lundbeck.com