Lundbeck will present MSA and Parkinson’s disease data at MDS 2026, including MASCOT Phase III findings and Lu AF28996 Phase Ib research.
Written By: Umesh Hanumante,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Lundbeck A/S will showcase data from its movement disorders pipeline at MDS 2026, with presentations spanning the Phase III development of amlenetug in MSA and exploratory clinical research with Lu AF28996 in advanced Parkinson’s disease (PD). The company said the program also includes research on clinical trial endpoints, biomarkers, diagnostic tools and healthcare resource utilization.
MASCOT Phase III Trial Evaluates Amlenetug in MSA
A key presentation will provide baseline characteristics from the ongoing MASCOT Phase III trial, which is evaluating amlenetug in people with MSA.
MASCOT (NCT06706622) enrolled 401 participants with clinically probable or clinically established MSA, including patients with both MSA-C and MSA-P. The randomized, double-blind, placebo-controlled trial is evaluating the safety and efficacy of amlenetug over a 72-week double-blind treatment period, with results expected in the third quarter of 2027.
Amlenetug is an investigational monoclonal antibody that binds to major forms of extracellular α-synuclein. Lundbeck is developing the therapy with the aim of preventing uptake and inhibiting the seeding of α-synuclein aggregation. The company states that amlenetug remains investigational and has not been approved by any regulatory authority.
Additional Research Addresses MSA Clinical Development
Beyond MASCOT, Lundbeck will present research addressing several challenges in MSA clinical development.
The program includes analyses of the modified Unified Multiple System Atrophy Rating Scale Part I (mUMSARS Part I) as a potential clinical trial endpoint for measuring functional decline. Additional presentations will cover validation of the Chinese version of UMSARS and cerebrospinal fluid biomarkers that may support disease detection, differential diagnosis and disease monitoring.
Lundbeck will also present findings from a US observational database study examining healthcare resource utilization and costs in MSA compared with Parkinson’s disease. According to the company, the study found significantly higher healthcare costs and healthcare resource utilization among people with MSA.
Lu AF28996 Phase Ib Program in Advanced Parkinson’s Disease
Lundbeck will also present exploratory Phase Ib data for Lu AF28996, an investigational 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 and motor fluctuations, with or without dyskinesia. The company will complement the clinical findings with preclinical research examining the relationship between dose, motor efficacy and dyskinesia in a primate model of Parkinson’s disease.
Lundbeck will present detailed Phase Ib findings for Lu AF28996 at MDS 2026 in a dedicated presentation titled “Lu AF28996, a Novel Oral D1-like/D2-like Receptor Agonist, Results from an 18-week open-label, Phase 1b Trial.” The presentation is scheduled as a de novo ePoster on October 6. The October 2 announcement provides details on the study design and planned presentation but does not include the clinical results.
Lu AF28996 is currently in Phase II development. Lundbeck says the ongoing 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.
MDS 2026 to Provide Broader View of Lundbeck’s Movement Disorders Pipeline
Lundbeck’s MDS 2026 program reflects a development strategy spanning investigational therapies as well as clinical measures and biomarkers intended to improve understanding and evaluation of movement disorders.
For MSA, the company is advancing amlenetug through the Phase III MASCOT program while investigating biomarkers, clinical endpoints and diagnostic approaches. In advanced Parkinson’s disease, Lu AF28996 is being evaluated as a potential oral approach for motor complications, with Phase Ib findings forming part of the company’s clinical development program.
The detailed clinical findings from the Lu AF28996 Phase Ib study will provide additional information on the investigational therapy’s clinical effects and safety profile. Lundbeck has stated that both Lu AF28996 and amlenetug remain investigational and have not been approved by any regulatory authority.
Reference
Lundbeck to showcase progress across its movement disorders pipeline with data in multiple system atrophy and Parkinson’s disease at MDS® 2026, Lundbeck, 02 October 2026
About the Writer
Umesh Hanumante (M.Pharm) (LinkedIn) is a pharmacy professional and healthcare writer with a background in Regulatory Affairs, pharmaceutical innovation, and clinical research. He has around two years of industry experience as an Executive PMT at Troikaa Pharmaceuticals Ltd and qualified GPAT 2024. His areas of interest include regulatory compliance, dossier preparation, clinical trials, emerging therapies, and advancements in the global pharmaceutical and healthcare sector.