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Neurocrine Biosciences Announces Phase 3 Pediatric Study Results of Crinecerfont in Children and Adolescents for the Treatment of Congenital Adrenal Hyperplasia Met Primary and Key Secondary Endpoints
CAHtalyst™ Pediatric Study Met Primary Endpoint Demonstrating a Statistically Significant Decrease from Baseline in Serum Androstenedione in Children and
About this update from Neurocrine Biosciences, Inc.
[{"type":"text","content":"CAHtalyst™ Pediatric Study Met Primary Endpoint Demonstrating a Statistically Significant Decrease from Baseline in Serum Androstenedione in Children and Adolescents with Congenital Adrenal HyperplasiaKey Secondary Endpoint Demonstrated a Statistically Significant Decrease from Baseline in Daily Glucocorticoid Dose while Maintaining Androgen Control Crinecerfont Was Generally Well-Tolerated Company to Host Conference Call and Webcast Today at 8:00 a.m. ET with Management and Dr. Richard Auchus, Professor of Pharmacology and Internal Medicine, Division of Metabolism, Endocrinology, and Diabetes at the University of Michigan SAN DIEGO, Oct. 5, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced positive top-line data from the Phase 3 CAHtalyst™ Pediatric Study evaluating the efficacy, safety, and tolerability of crinecerfont in children and adolescents with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. Crinecerfont is an oral, selective corticotropin-releasing factor type 1 receptor antagonist being investigated to help reduce and control excess adrenal androgens through a steroid-independent mechanism.\n\n \n \n \n \n \n \n\n \n\"The outstanding safety and efficacy results reported today for the CAHtalyst Pediatric study and last month for the CAHtalyst Adult study demonstrate the potential benefit of crinecerfont across all groups studied, including children, adolescents and adults,\" said Kevin Gorman, Ph.D., Chief Executive Officer, Neurocrine Biosciences, Inc.\n\"As a pediatric endocrinologist, I'm highly encouraged by the results from the CAHtalyst Pediatric study and the potential of crinecerfont to shift the treatment paradigm for a disorder that has seen little innovation in many decades,\" said Kyriakie Sarafoglou, M.D., Professor, Department of Pediatrics and Department of Experimental and Clinical Pharmacology, Divisions of Endocrinology and Genetics & Metabolism, University of Minnesota. \"The data suggest that crinecerfont might enable us to smooth out the numerous adjustments we have to make in glucocorticoid doses to manage high androgen levels as children grow, potentially improving clinical outcomes related to androgen excess as well as chronic supraphysiologic glucocorticoid dosing.\"\nThe Phase 3 Pediatric study met its primary endpoint, demonstratin...