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Spruce Biosciences Announces Publication of Phase 2 Results for Tildacerfont in Journal of Clinical Endocrinology and Metabolism
Tildacerfont was Evaluated in Two Phase 2 Open-Label Studies in Adults with Classic Congenital Adrenal Hyperplasia (CAH) Data Demonstrated Normalization or
About this update from Spruce Biosciences, Inc.
[{"type":"text","content":"\nTildacerfont was Evaluated in Two Phase 2 Open-Label Studies in Adults with Classic Congenital Adrenal Hyperplasia (CAH)\n\nData Demonstrated Normalization or Trend to Normalization in Key Hormone Biomarkers \n\nTildacerfont is First CRF1 Receptor Antagonist Studied Beyond 2 Weeks in CAH\n\n SAN FRANCISCO--(BUSINESS WIRE)--\nSpruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need, today announced the publication of the results from two Phase 2 clinical studies investigating tildacerfont in adult patients with classic CAH in the Journal of Clinical Endocrinology and Metabolism.\n\n“The data published in the Journal of Clinical Endocrinology and Metabolism demonstrates the potential of tildacerfont to reduce androgen excess without increasing the total daily glucocorticoid dose in patients with classic CAH,” said Kyriakie Sarafoglou, MD, Associate Professor, Department of Pediatrics – Divisions of Endocrinology and Genetics & Metabolism at the University of Minnesota Medical School.\n\nSPR001-201 was an open-label, multi-dose, Phase 2a dose-escalation study which evaluated the ability of tildacerfont to lower adrenocorticotropic hormone (ACTH), 17-hydroxyprogesterone (17-OHP), and androstenedione (A4) at doses ranging from 200mg daily to 1,000mg daily in patients with congenital adrenal hyperplasia due to 21-hydroxylase deficiency. SPR001-202 was an open-label, 12-week Phase 2a clinical trial, which assessed the ability of a daily dose of 400mg of tildacerfont to lower ACTH, 17-OHP, and A4 over a 12-week dosing period. SPR001-201 and SPR001-202 comprised the entire Phase 2a clinical development program for tildacerfont in adult classic CAH. In the studies, efficacy was evaluated by changes from baseline in ACTH, 17-OHP, and A4 according to baseline A4 ≤2x upper limit of normal (ULN), denoted as baseline good disease control, or A4 >2x ULN, denoted as baseline poor disease control. Safety was evaluated using adverse events and laboratory assessments.\n\nThe results of the studies showed that tildacerfont reduced key hormone biomarkers towards normal levels in the baseline poor disease control group, including normalization of ACTH and A4 in 60% and 40% of patients, respectively. In pat...