H. Lundbeck A/S 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.
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 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.
