Spruce Biosciences, Inc. 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). Anticipated Upcoming Milestones: Completion of enrollment in CAHmelia-204 clinical trial in adult classic CAH patients on supraphysiologic doses of glucocorticoids with normal or near normal levels of androstenedione (A4) in January 2024. Topline results from the CAHmelia-203 clinical trial in adult classic CAH patients with highly elevated levels of A4 in March 2024.

Topline results from all cohorts in the CAHptain-205 clinical trial in pediatric classic CAH patients in March 2024. Topline results from the CAHmelia-204 clinical trial in adult classic CAH patients on supraphysiologic doses of glucocorticoids with normal or near normal levels of A4 in the third quarter of 2024. Tildacerfont Program Updates: Late-Stage CAHmelia Program in Adult Classic CAH - CAHmelia-203 Study in Adult Classic CAH Completes Enrollment: Enrollment in CAHmelia-203 is complete with 96 patients, surpassing target enrollment of 72 patients.CAHmelia-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 A4 at baseline while on stable glucocorticoid dosing.

The primary endpoint of the clinical trial is the percentage change in A4 from baseline at week 12. Topline results from the study are anticipated in March 2024. Enrollment for CAHmelia-204 Study in Adult Classic CAH to be Completed in January 2024: Enrollment in CAHmelia-204 is anticipated to be completed in January 2024, and will surpass target enrollment of 90 patients.CAHmelia-204 is a randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of tildacerfont in reducing supraphysiologic glucocorticoid usage in adults with classic CAH in patients on supraphysiologic doses of glucocorticoids with normal or near normal levels of A4 at baseline.

Based on a statistical analysis of aggregated blinded data, the primary endpoint of this clinical trial is now the absolute change in glucocorticoid dose from baseline at week 24. Topline results from the study are anticipated in the third quarter of 2024. Pediatric Classic CAH Program: CAHptain-205 Study in Pediatric Classic CAH Completes Enrollment: Enrollment in CAHptain-205 is complete with 30 patients, surpassing target enrollment of 20 patients.

CAHptain-205 is a Phase 2 open-label clinical trial, which utilizes a sequential three cohort design, to evaluate the safety, efficacy, and pharmacokinetics of tildacerfont in children two to 17 years of age. The primary endpoint of this clinical trial is safety. Additional secondary endpoints include the proportion of subjects who achieve reduction in A4 or daily glucocorticoid dosing at week 12 and the proportion of subjects with elevated A4 at baseline who achieve a reduction in A4 at week 4. Topline results from the study are anticipated in March 2024.