Neurocrine Biosciences Presents Post Hoc Data Analysis in Congenital Adrenal Hyperplasia at ESPE 2023

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[{"type":"text","content":"SAN DIEGO, Sept. 21, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced that it will present a new post hoc analysis of Phase 2 data of the investigational drug crinecerfont in adolescent patients with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD). The analysis suggests that adolescents with classic CAH who have more elevated baseline hormone levels may have the potential for a greater response to treatment with crinecerfont and may experience a reduction in androgen levels across a broad range of glucocorticoid doses. These new data will be presented at the 61st Annual European Society for Pediatric Endocrinology (ESPE) Meeting in The Hague, Netherlands from Sept. 21–23, 2023.\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 (17-OHP), adrenocorticotropic hormone (ACTH) and androstenedione (A4) in adolescents (ages 14–16) with CAH due to 21-OHD. Post hoc analysis of these data released today assessed whether baseline hormone concentration and glucocorticoid (GC) doses correlated with response to treatment. A strong correlation was found between baseline hormone concentration and change from baseline to Day 14 for 17-OHP, ACTH and A4, with the greatest reductions observed in participants with the highest baseline hormone levels. These data suggest adolescents with higher baseline hormone concentrations may have the potential for a greater response to treatment with crinecerfont. However, there was no correlation between baseline GC dose and treatment response, which suggests that androgen reduction might occur across a broad range of GC doses in this population.\nIn the Phase 2 study, crinecerfont was generally well tolerated in adolescents, with no serious adverse events or discontinuations due to adverse events. There were no safety concerns with respect to routine laboratory tests, vital signs, electrocardiograms or neuropsychiatric assessments.\nThe results of the post hoc analysis in adolescents were consistent with results from similar post hoc analyses of the Phase 2 study of crinecerfont in adults with classic CAH, suggesting that higher baseline hormone concentrations might predict greater response, and androgen reduction might occ...

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