Lundbeck Reports Positive Phase 1b Results for Lu AF28996 in Advanced Parkinson's Disease
Key Insights
Lundbeck's Phase 1b trial of Lu AF28996, a novel dopamine D1/D2 receptor agonist, demonstrated good tolerability and early signals consistent with its mechanism of action in advanced Parkinson's disease patients.
The oral investigational therapy aims to address motor fluctuations and "OFF" time periods that persist despite current treatments in advanced Parkinson's disease.
Based on positive Phase 1 results, Lundbeck is initiating a Phase 2 study in 2026 to further evaluate Lu AF28996's potential in advanced Parkinson's disease patients.
H. Lundbeck A/S announced positive results from a Phase 1b proof-of-mechanism trial of Lu AF28996, an investigational oral dopamine D1/D2 receptor agonist for advanced Parkinson's disease, at the 2026 Alzheimer's and Parkinson's Disease conference in Copenhagen.
The Phase 1b trial evaluated 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.
Addressing Unmet Medical Need in Advanced Parkinson's
People with advanced Parkinson's disease frequently experience motor fluctuations, including periods of persistent reduced mobility known as "OFF" time, despite available treatments. Current pharmacological options may also be associated with treatment-related motor complications such as dyskinesia, whereas device-aided delivery methods present several practical limitations. 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."
Novel Mechanism and Development Timeline
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.
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.
Expanding Pipeline in Movement Disorders
In addition to the Parkinson's disease program, Lundbeck presented insights into multiple system atrophy (MSA), a rapidly progressing and fatal neurodegenerative disease for which no approved treatments currently exist. The data highlighted advances in the understanding of MSA disease progression and the advantages of using Bayesian progression modeling to assess clinical trial outcomes in MSA.
Presentations also underscored 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.
Amlenetug is a human monoclonal antibody 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.
With multiple poster and oral presentations accepted at AD/PD 2026, Lundbeck demonstrates the breadth of its Research and Development program in movement disorders and continued dedication to advancing innovative therapies for patients with severe neurological conditions.