Lundbeck to present phase 1b data on Lu AF28996, an investigational treatment for people with advanced Parkinson’s disease at the 2026 AD/PD conference

H Lundbeck A/S (Lundbeck), a biopharmaceutical company focusing exclusively on brain health, 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. 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.”

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.

The data will highlight advances in the understanding of MSA disease progression and the advantages of using Bayesian progression modelling 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 programme in MSA.

With multiple poster and oral presentations accepted at AD/PD 2026, Lundbeck demonstrates the breadth of its Research and Development (R&D) programme 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.

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.

Amlenetug is a human monoclonal antibody (mAb) that recognizes and binds to all major forms of extracellular a-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.

H. Lundbeck A/S 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.