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Neurocrine Biosciences Presents Data on Treatment of Patients with Congenital Adrenal Hyperplasia at ECE 2023
Post Hoc Analyses of Phase 2 Study of Crinecerfont in Adults with CAH Demonstrate Androgen Reduction Across a Broad Range of Glucocorticoid DosesPost Hoc
About this update from Neurocrine Biosciences, Inc.
[{"type":"text","content":" Post Hoc Analyses of Phase 2 Study of Crinecerfont in Adults with CAH Demonstrate Androgen Reduction Across a Broad Range of Glucocorticoid DosesPost Hoc Analyses of Phase 3 Study Demonstrate EFMODY® (hydrocortisone modified-release hard capsules) Reduced Androgen Levels Compared to Immediate-Release Hydrocortisone in Patients with CAHSAN DIEGO, May 12, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, today announced that it will present new analyses of Phase 2 data of the investigational drug crinecerfont in adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD) and post hoc analyses of Phase 3 data for EFMODY® (hydrocortisone modified-release hard capsules). EFMODY is approved by the European Commission for the European Economic Area (including Northern Ireland) (EEA) and by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of adults and adolescents (12 years and older) with CAH. These new data and an additional poster showing Phase 2 data of crinecerfont in adolescents with classic CAH will be presented at ECE 2023, the 25th European Congress of Endocrinology in Istanbul, Turkey from May 13–16.\n\n \n \n \n \n \n \n\n \nIn previously reported Phase 2 study data, crinecerfont treatment for 14 days led to clinically meaningful reductions of 17–hydroxyprogesterone (17OHP), adrenocorticotropic hormone (ACTH), and androstenedione in adults with classic CAH due to 21-OHD. Post hoc analyses of these data released today assessed whether baseline hormone levels and glucocorticoid (GC) doses correlated with treatment response. A strong correlation was found between baseline level and change from baseline to Day 14 for 17OHP, ACTH, and androstenedione, with the greatest reductions from baseline observed in subjects with the highest baseline hormone level. These results indicate that adults with classic CAH who have more elevated baseline hormone levels have the potential for a greater response to treatment with crinecerfont. However, reductions in androgen levels were seen in patients regardless of their GC dose at baseline. See the abstract (Poster #274; Response to Crinecerfont Treatment in Adults with Classic Congenital Adrenal Hyperplasia is Correlated with Elevated Baseline Hormon...