Lundbeck reports Phase II success for asedebart in Cushing’s disease

The study focused on asedebart (Lu AG13909), a monoclonal antibody engineered to neutralize excess adrenocorticotropic hormone (ACTH). By blocking ACTH from binding to the melanocortin 2 receptor in adrenal glands, the drug aims to curtail the chronic cortisol overproduction that characterizes the condition. Among the 12 patients enrolled in the trial, 8 completed an individualized intravenous dose titration. Of those, 7 achieved cortisol normalization—defined as 170 nmol/24 hours or less.

Johan Luthman, Lundbeck’s executive vice president of research and development, noted that the results validate the company's shift toward neurohormonal signaling targets. While the drug was generally well-tolerated, researchers observed treatment-emergent adverse events across the entire participant group, and three patients experienced serious complications, including one unrelated death. Lundbeck is now moving to Part B of the study, which will evaluate a subcutaneous formulation to assess safety, pharmacokinetics, and patient experience. Asedebart remains an investigational therapy and has not yet received regulatory approval for commercial use.