VALBY, Denmark, March 16, 2026 /PRNewswire/ -- H. Lundbeck A/S (Lundbeck) today announced that new data from a Phase 1b proof-of-mechanism trial of Lu AF28996, a novel compound invented by Lundbeck with dopamine D1/D2 receptor agonist activity, will be presented at the 2026 Alzheimer's and Parkinson's Disease (AD/PD™) conference in Copenhagen, Denmark (17-21 March).
The Phase 1b trial evaluated the safety, tolerability, pharmacokinetics and exploratory clinical activity of orally administered Lu AF28996 in people with advanced Parkinson's disease. Results indicate that Lu AF28996 was generally well tolerated and demonstrated early signals consistent with its proposed mechanism of action, supporting continued clinical development.
People with advanced Parkinson's disease frequently experience motor fluctuations, including periods of persistent reduced mobility known as "OFF" time, despite available treatments.1,2 Current pharmacological options may also be associated with treatment-related motor complications such as dyskinesia,1 whereas device-aided delivery methods present several practical limitations.3 These challenges reinforce the importance of developing innovative therapies with acceptable tolerability and ease of use for patients with advanced Parkinson's disease.
"Phase 1b patient trials are an important step in understanding the safety profile and biological activity of new investigational therapies in early clinical development," said Johan Luthman, EVP and Head of Research & Development at Lundbeck. "These data provide supportive evidence to further evaluate the potential of Lu AF28996 in the treatment of people with advanced Parkinson's disease."
In addition, Lundbeck will present insights into multiple system atrophy (MSA), a rapidly progressing and fatal neurodegenerative disease for which no approved treatments currently exist.4
The data will highlight advances in the understanding of MSA disease progression and the advantages of using Bayesian progression modeling to assess clinical trial outcomes in MSA.
Presentations will also underscore the importance of integrating patient perspectives into MSA trial design, and progress in biomarker development to enable earlier diagnosis. These learnings have directly informed Lundbeck's amlenetug pivotal program in MSA.
With multiple poster and oral presentations accepted at AD/PD™ 2026, Lundbeck demonstrates the breadth of its Research and Development (R&D) program in movement disorders and continued dedication to advancing innovative therapies for patients with severe neurological conditions.
Lu AF28996 and amlenetug are investigational compounds which have not been approved for use by any regulatory authority. The efficacy and safety of both compounds have not been established.
Lundbeck's scientific program at AD/PD™:
Oral D1/D2-agonist Lu AF28996: Efficacy and tolerability in people with Parkinson's disease with motor fluctuations and with/without dyskinesia – Open-label phase 1b results | Oral presentation:Alberto Cucca | Weds 18 Mar 16:00 - 16:15 CET |
Interpretation of Clinical Progression in Multiple System Atrophy Using Percentage-Wise Slowing in the Unified Multiple System Atrophy Rating Scale Score | Poster presentation:Anna Karin Berger | Tues 17 Mar – Thurs 19 |
Mass spectrometry assay for measuring truncated α-Synuclein protein levels in CSF from Multiple System Atrophy vs Parkinson's disease | Poster presentation:Pekka Kallunki | Tues 17 Mar – Thurs 19 |
Assessing disease progression in MSA: Development of a Bayesian Progression Model | Poster presentation:Jonas Wiedemann | Thurs 19 Mar – Sat 21 |
Incorporating the patient voice on a protocol for a clinical trial assessing progression in MSA | Poster presentation:Beatrice Yang | Thurs 19 Mar – Sat 21 |
Scientific symposium: α-synuclein in MSA: Bridging pathophysiology, biomarker discovery and targeted therapies | SpeakersProf. Höglinger Prof. van de BergProf. Compta | Tues 17 Mar 9:30 -10:30 CET |
Forum talk: Targets to Therapies "Translational R&D for α-synuclein, LRRK2, and GBA pathologies in PD, LBD and MSA | SpeakersJamie Eberling (US)Keneth Marek (US)Johannes Streffer (DK) | Fri 20 Mar17:30 - 18:30 CET |
About Lu AF28996
Lu AF28996 is a novel, orally administered D1-like/D2-like receptor agonist discovered by Lundbeck. It is designed to provide continuous dopaminergic stimulation and is being investigated for its potential to improve motor fluctuations and levodopa induced dyskinesia in people with Parkinson's disease. Lu AF28996 is currently in early clinical development.
The Phase 1 study evaluated the safety, tolerability and pharmacodynamics of Lu AF28996 in healthy volunteers and Parkinson's disease patients. Based on these results Lundbeck is initiating a Phase 2 study in 2026 in people with advanced Parkinson's Disease.
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.
Contacts:
Anders Crillesen,
Head of Media Relations, Corp. Communication
AECE@lundbeck.com
+45 27 79 12 86
Jens Høyer
Vice President, Head of Investor Relations
JSHR@lundbeck.com
+45 30 83 45 01
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:
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