The preliminary data from Part A of the study focused on patients with Cushing’s disease of pituitary origin, a condition driven by chronic hypercortisolism. By neutralizing excess ACTH, asedebart aims to interrupt the signaling pathway that leads to the overproduction of cortisol. Among the 12 enrolled patients, 8 began the intravenous dosing phase, with 7 successfully reaching the threshold for urinary free cortisol normalization at 170 nmol/24 hours or less.
Lundbeck Reports Positive Phase II Results for Asedebart in Cushing's
Seven out of eight evaluable patients achieved normalized cortisol levels during a Phase II trial of asedebart, a novel monoclonal antibody targeting adrenocorticotropic hormone. The findings, presented at the Endocrine Society's annual meeting in Chicago, offer a potential new therapeutic path for treating the underlying causes of Cushing's disease.
Lundbeck reported that the drug was generally well tolerated throughout the titration period. While treatment-emergent adverse events occurred in all participants, no new safety signals emerged. The company is now pivoting to Part B of the study, which will evaluate a subcutaneous formulation of the antibody to further assess its efficacy, pharmacokinetics, and impact on patient experience. Asedebart currently holds Orphan Drug Designation in both the United States and the European Union for its potential application in Cushing's disease and congenital adrenal hyperplasia.
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