Spruce to report results of CAHmelia-203 and CAHptain-205 in March 2024

Spruce Biosciences provided an update on its clinical programs, upcoming milestones and strategic priorities for advancing tildacerfont for the treatment of adult and pediatric classic congenital adrenal hyperplasia, CAH. “2023 was a year of exceptional clinical execution across the board, and we were pleased to reach important milestones by completing enrollment in CAHmelia-203 for adult classic CAH and CAHptain-205 for pediatric classic CAH,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “We’re also nearing completion of enrollment in CAHmelia-204 for adult classic CAH and look forward to maintaining this momentum with a catalyst-heavy 2024, and plan to report topline results from CAHmelia-203 and CAHptain-205 in March 2024, along with results from CAHmelia-204 in the third quarter of 2024.” Dr. Szwarcberg continued, “There is a significant unmet medical need in children and adults with CAH to alleviate the systemic risks and comorbidities associated with hyperandrogenemia and chronic overexposure to glucocorticoids or GCs. Tildacerfont, if approved, has the potential to alter the treatment paradigm by providing a new and potentially novel, once-daily, non-steroidal treatment option that reduces adrenal hormones and alleviates the daily burden of supraphysiologic exposure to GCs. We are committed to unlocking the full therapeutic potential of tildacerfont and delivering a quantifiable and meaningful improvement over today’s standard of care in CAH.”