Asedebart Shows Encouraging Early Signal in Cushing's Disease

Research evidence excerpt

Asedebart Shows Encouraging Early Signal in Cushing's Disease

ept, with data from Part B (subcutaneous

formulation) as the next key catalyst. Hypocortisolism and serious AE rates will need watching

as the dataset scales. Primary completion is expected 15 Sept. We forecast $750m WW

asedebart sales in CD and congenital adrenal hyperplasia (CAH), risk-adjusted at 20%, for

DKK0.9/share NPV (2%).

ACTH neutralisation provides a differentiated upstream approach: Asedebart targets

circulating ACTH directly, addressing the proximal driver of cortisol excess in ACTH-driven

disease, in contrast to existing therapies that act downstream, either inhibiting adrenal cortisol

synthesis or blocking cortisol signalling at the receptor level. Pituitary-directed agents aim

to suppress ACTH secretion but have shown variable efficacy and tolerability. By intervening

upstream, ACTH neutralisation may offer a more targeted and controllable reduction in

cortisol. Additionally, it may allow for fewer side effects compared to glucocorticoids in CAH,

and may address mental comorbidities in CD.

Asedebart being studied in additional indication congenital adrenal hyperplasia: In parallel

to CD, Lundbeck is developing asedebart in CAH, with an ongoing Phase I/II study evaluating

safety, PK/PD and hormonal effects in adults. The programme has already transitioned into

the Phase II component, which is fully enroled, following early signals of androgen reduction,

and is designed to assess whether ACTH neutralisation can control hyperandrogenism while

addressing the complications of long-term glucocorticoid overexposure. Primary completion

is expected 30 Sept.

Orphan designation underscores strategic positioning in rare endocrine: Asedebart has Shan Hama * | Equity Analyst