Spruce Biosciences reports results from CAHmelia-203 study of tildacerfont

Spruce Biosciences “announced topline results from its CAHmelia-203 study of tildacerfont in adult classic congenital adrenal hyperplasia and its CAHptain-205 study of tildacerfont in pediatric classic CAH. Spruce 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. The 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.”