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Spruce Biosciences Completes Target Enrollment of CAHmelia-203 Study in Adult Classic Congenital Adrenal Hyperplasia
Final Enrollment in CAHmelia-203 to Exceed Target Due to Substantial Patient Interest CAHmelia-203 Topline Results Anticipated in the First Quarter of 2024
About this update from Spruce Biosciences, Inc.
[{"type":"text","content":"\nFinal Enrollment in CAHmelia-203 to Exceed Target Due to Substantial Patient Interest\n\n\nCAHmelia-203 Topline Results Anticipated in the First Quarter of 2024\n\n\nCAHmelia-204 Completion of Enrollment Anticipated in Early First Quarter of 2024\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 completion of target enrollment of 72 patients and closure of screening in the CAHmelia-203 clinical trial evaluating tildacerfont for the treatment of adult classic congenital adrenal hyperplasia (CAH) and provided updated anticipated milestones.\n\n\n“Completing target enrollment in the CAHmelia-203 study is a significant milestone for our CAH program and reflects the continued strong enthusiasm from patients and study investigators alike, evidences the large unmet medical need in the CAH community, and reinforces the momentum within our broader tildacerfont program,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “Due to substantial patient interest in CAHmelia-203, eligible adult patients currently in screening will be allowed to enter the trial. As a result, we anticipate that final enrollment will exceed our original target of 72 patients, and project topline results from this study along with the topline results from all cohorts in our CAHptain clinical trial in pediatric classic CAH in the first quarter of 2024.”\n\n\nCAHmelia-203 is a randomized, double-blind, placebo-controlled, dose ranging Phase 2b clinical trial evaluating the safety and efficacy of tildacerfont in adults with classic CAH and highly elevated levels of androstenedione (A4) at baseline while on stable glucocorticoid dosing. Tildacerfont is a once-daily, potent and highly selective, non-steroidal, oral antagonist of the corticotropin-releasing factor (CRF) 1 receptor. The primary endpoint of the clinical trial is the percentage change in A4 from baseline to week 12 with secondary endpoints including the proportion of patients with levels of 17-hydroxyprogesterone (17-OHP) and A4 within the target and normal range, respectively, and change in lesion volume of testicular adrenal rest tumors (TARTs) in me...