The Morrisville, NC-headquartered contract research organization (CRO) Worldwide Clinical Trials (Worldwide) will initially support the US clinical development of Diurnal’s cortisol replacement product, Chronocort.
Diurnal CEO Martin Whitaker, PhD, said the US represents an estimated total market opportunity of approximately $1bn billion for Chronocort in both congenital adrenal hyperplasia (CAH) and adrenal insufficiency (AI).
The planned Phase III study will recruit up to 150 patients with CAH and is expected to halfway through the year.
Worldwide will also conduct a Phase II study of Chronocort in AI patients. The study is expected to launch around the end of 2018.