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.”