By Joe Hoppe
Diurnal Group PLC said Monday that the U.S. Food and Drug Administration has agreed a special protocol assessment, or SPA, to study its Chronocort treatment for the rare condition congenital adrenal hyperplasia.
The pharmaceutical company said the SPA agrees that the study design addresses objectives that would support a regulatory submission of the treatment for approval. A Phase 3 trial is expected to begin in the U.S. in the second half of the year.
The company said it has already begun start-up activities, and will look to recruit 150 patients with congenital adrenal hyperplasia to be treated for a year.
The condition is estimated to affect around 16,000 patients in the U.S., and around two-thirds of patients are estimated to have poor disease control.
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View more information: https://www.marketwatch.com/story/diurnal-receives-agreement-from-fda-for-study-of-chronocort-treatment-271626072088