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Spruce Biosciences Announces Topline Results from CAHmelia-204 in Adult CAH and CAHptain-205 in Adult and Pediatric CAH
CAHmelia-204 Study of 200mg Once-Daily (QD) Tildacerfont in Adult Congenital Adrenal Hyperplasia (CAH) Did Not Achieve Primary Endpoint of Glucocorticoid
About this update from Spruce Biosciences, Inc.
[{"type":"text","content":"\nCAHmelia-204 Study of 200mg Once-Daily (QD) Tildacerfont in Adult Congenital Adrenal Hyperplasia (CAH) Did Not Achieve Primary Endpoint of Glucocorticoid (GC) Reduction\n\n\nDose-Ranging Data from CAHptain-205 Study of Tildacerfont in Adult and Pediatric CAH Suggests Higher Doses and Twice-Daily (BID) Dosing May Be Necessary for Efficacy in CAH\n\n\nEvaluation of Strategic Opportunities and Cost-Reduction Activities Underway\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 neurological and endocrine disorders with significant unmet medical need, today announced topline results from its CAHmelia-204 study of tildacerfont in adult CAH and its CAHptain-205 study of tildacerfont in adult and pediatric CAH.\n\n\n“We are very grateful to all the patients, families, investigators, and the entire CAH community who supported the CAHmelia-204 and CAHptain-205 clinical trials. We garnered invaluable safety and exposure response data on tildacerfont from these studies, which suggests that higher doses and more frequent dosing may be necessary for efficacy in CAH,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce. “Moving forward, we plan to evaluate a full range of strategic options for Spruce in addressing diseases with serious unmet need for patients. In the interim, the CAHmelia-204 and CAHptain-205 clinical trials will be discontinued, and we will be winding down Spruce’s investment in tildacerfont for the treatment of CAH as we conserve financial resources and look to maximize shareholder value.”\n\n\nCAHmelia-204 was a Phase 2b, randomized, double-blind, placebo-controlled clinical trial that evaluated the safety and efficacy of tildacerfont in reducing supraphysiologic GC usage in 100 adults with classic CAH on a mean GC dose of 35mg/day of hydrocortisone equivalents (HCe) (19mg/m2/day) and mean androstenedione (A4) level of 214 ng/dL at baseline.\n\n\nThe clinical trial did not achieve the primary efficacy endpoint of the absolute change in daily GC dose from baseline at week 24. 200mg QD of tildacerfont demonstrated a placebo-adjusted reduction from baseline in daily GC dose of 0.7mg HCe (95% CI: -4.3 to 2.9, p=0.7). Approximately 98% of patients were highly comp...