Business
Spruce Biosciences Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Updates
Topline Safety Data from Cohort 1 of Phase 2 Pediatric Classic CAH Study Expected by 1H 2023 Will Charlton, M.D., M.A.S., Appointed Chief Medical Officer SAN
About this update from Spruce Biosciences, Inc.
[{"type":"text","content":"\nTopline Safety Data from Cohort 1 of Phase 2 Pediatric Classic CAH Study Expected by 1H 2023\n\nWill Charlton, M.D., M.A.S., Appointed Chief Medical Officer\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 reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update.\n\n“Over the last quarter, we have made notable progress in our efforts to advance new treatment options for people living with rare endocrine disorders and to maximize the potential of tildacerfont as a therapeutic to treat people living with classic congenital adrenal hyperplasia (CAH) and polycystic ovary syndrome (PCOS),” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “We are expanding the number of study sites globally and rolling out updated protocols for the CAHmelia-203 and CAHmelia-204 clinical trials in adult classic CAH, which we expect will accelerate patient enrollment. We were also pleased to initiate our Phase 2 clinical trials in patients with pediatric classic CAH and PCOS and expect topline results from both studies by the first half of 2023.”\n\nCorporate Updates\n\n\nTopline Safety Data from Cohort 1 of Phase 2 Pediatric Classic CAH Study Expected by 1H 2023: Spruce is investigating tildacerfont for the treatment of classic CAH in children and recently initiated a Phase 2 clinical trial. There is a significant unmet medical need to bring androgen-lowering and glucocorticoid-sparing therapies to pediatric classic CAH patients to reduce the risk of premature puberty and the adverse effects of glucocorticoids, including stunted growth resulting in short stature as adults. The Phase 2 open-label clinical trial will utilize a sequential 3 cohort design to evaluate the safety and pharmacokinetics of tildacerfont in children six to 17 years of age with classic CAH.\n\n\nWill Charlton, M.D., M.A.S., Appointed Chief Medical Officer: In March 2022, Will Charlton, M.D., M.A.S, was appointed Chief Medical Officer of Spruce Biosciences, and will lead the company’s clinical development and global drug development strategy. Dr. Charlton is a board-certified pediatric e...