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Spruce Biosciences Announces Topline Results from CAHmelia-203 in Adult Classic CAH and CAHptain-205 in Pediatric Classic CAH
CAHmelia-203 Study of Tildacerfont in Adult Classic Congenital Adrenal Hyperplasia (CAH) with Severe Hyperandrogenemia Did Not Meet Primary Efficacy Endpoint
About this update from Spruce Biosciences, Inc.
[{"type":"text","content":"\nCAHmelia-203 Study of Tildacerfont in Adult Classic Congenital Adrenal Hyperplasia (CAH) with Severe Hyperandrogenemia Did Not Meet Primary Efficacy Endpoint\n\n\nPositive Data from CAHptain-205 Study of Tildacerfont in Pediatric Classic CAH Supports Further Dose-Ranging Across Additional Dosing Cohorts\n\n\nTopline Results from CAHmelia-204 Study of Tildacerfont in Adult Classic CAH Evaluating Glucocorticoid (GC) Reduction Anticipated in Third Quarter of 2024\n\n\nResource Prioritization and Cost Reductions Extend Cash Runway Through End of 2025\n\n\nConference Call Today at 4:30 p.m. ET\n\n\n SOUTH SAN FRANCISCO, Calif.--(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 topline results from its CAHmelia-203 study of tildacerfont in adult classic congenital adrenal hyperplasia (CAH) and its CAHptain-205 study of tildacerfont in pediatric classic CAH.\n\n\nSpruce is investigating tildacerfont, a second generation, once-daily oral antagonist of the CRF1 receptor, for the treatment of classic CAH. The global CAHmelia program in adult classic CAH is comprised of two Phase 2b studies designed to address the unmet medical needs of two distinct populations of adult CAH patients. CAHmelia-203 assesses androstenedione (A4) reduction in adult CAH patients with severe hyperandrogenemia, while CAHmelia-204 assesses glucocorticoid (GC) reduction, a potentially registrational endpoint, in adult CAH patients on supraphysiologic GC doses with normal or near normal levels of A4.\n\n\nThe Phase 2 CAHptain-205 study is focused on addressing the unmet medical need in pediatric CAH patients, which represents approximately 25% of the total patient population. The CAHmelia and CAHptain programs seek to address the unmet medical need across the entire spectrum of the CAH patient community, which has not seen a new standard of care since GCs were introduced in the 1950s.\n\n\nCAHmelia-203 Study of Tildacerfont in Adult Classic CAH\n\n\nCAHmelia-203 enrolled 96 subjects with a mean baseline A4 level of 1,151 ng/dL, which is more than five times above the upper limit of normal (ULN).\n\n\nData Highlights\n\n\n\nThe clinical trial did not achieve the primary efficacy ...