Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPR001 · 2 trials · 3 indications
Incidence of treatment-emergent adverse events including any serious adverse events, dose-limiting toxicities, and adverse events leading to discontinuation of study drug.
Incidence of treatment-emergent adverse events, changes from Baseline to End-of-study in clinical laboratory parameters, physical examination findings, vital signs, ECG parameters
Change in 17-hydroxyprogesterone from Baseline to End-of-study. Results are expressed as mean percent change from baseline. Reductions in 17-OHP are indicators of better disease control.
| Arm | Type | Description |
|---|---|---|
| SPR001 | EXPERIMENTAL | SPR001 at Dose A |
| Cohort A | EXPERIMENTAL | The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks. |
| Cohort B | EXPERIMENTAL | Cohort B will begin enrollment after Cohort A has been fully enrolled. Starting dose selection and the stepwise dosing paradigm for Cohort B will be determined by an interim review of safety and PK/PD data from from Cohort A. |
| Cohort C | EXPERIMENTAL | Cohort C will begin enrollment after Cohort B has been fully enrolled. Starting dose selection and the stepwise dosing paradigm for Cohort C will be determined by an interim review of safety and PK/PD data from from Cohort A and B. |
| Name | Type | Description |
|---|---|---|
| SPR001 | DRUG | Open label SPR001 |
Inclusion Criteria: * Is approved by the Sponsor's Medical Monitor * Is on a stable regimen of glucocorticoid replacement for ≥30 days before baseline that is expected to remain stable throughout the study * If screening for this study occurs \>3 months after the subject's final follow-up visit in ...
SPR001 is an investigational small molecule being developed for the treatment of Congenital Adrenal Hyperplasia (CAH), a group of inherited endocrine disorders. It is currently in Phase 2 clinical development and has been studied in adult patients with classic CAH, including those with 21-hydroxylase deficiency.
SPR001 is being developed by Spruce Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SPRB. The company is conducting clinical trials to evaluate the safety and efficacy of SPR001 in patients with Congenital Adrenal Hyperplasia.
SPR001 is in Phase 2 clinical development. Two Phase 2 clinical trials have been completed, with a total of 35 adult patients enrolled. The drug is investigational and has not been approved by regulatory authorities, as it is still undergoing clinical evaluation.
SPR001 has been studied in two completed Phase 2 clinical trials. The first trial, NCT03257462, enrolled 24 adults with classic Congenital Adrenal Hyperplasia in the United States. The second trial, NCT03687242, enrolled 11 adults with classic CAH, including those with 21-hydroxylase deficiency, also in the United States.
SPR001 is the investigational name used by Spruce Biosciences for its small molecule candidate. No alternative names for SPR001 have been disclosed in the clinical trial records, and it is distinct from other marketed or investigational therapies for Congenital Adrenal Hyperplasia.