Our clinical trials of tildacerfont in adults with classic CAH, CAHmelia 203 and CAHmelia 204, are open for screening | LEARN MORE

Pipeline

Tildacerfont is a CRF1 receptor antagonist designed to potentially offer markedly improved disease control and reduced steroid burden in patients with classic congenital adrenal hyperplasia (CAH) and other diseases characterized by elevated levels of adrenocorticotropic hormone (ACTH). Tildacerfont binds to CRF1 receptors on the pituitary gland, inhibiting excessive production of ACTH, and ultimately limiting the production of adrenal androgens such as androstenedione, a precursor to testosterone.

Product Candidates

Product CandidateIndicationStatus
TildacerfontAdult Classic Congenital Adrenal HyperplasiaCAHmelia-203 and CAHmelia-204, evaluating adrenal androgen control, glucocorticoid reduction and related clinical outcomes, are in progress
Pediatric Classic Congenital Adrenal HyperplasiaPhase 2 trial in children planned in 2021
Polycystic Ovary Syndrome Filing of U.S. IND and initiation of Phase 2 proof of concept trial planned in 2021

Tildacerfont:
How It Works

Tildacerfont is in late-stage trials for the treatment of adult classic CAH, with a Phase 2 trial planned in pediatric CAH.

Completed
Clinical Trials

Tildacerfont has been evaluated in eight clinical trials to date in 235 patients, including two Phase 2 clinical trials in patients with classic CAH: a two-week proof of mechanism dose-ranging trial, and a 12-week proof of concept trial. In the 12-week trial, tildacerfont treated patients with highly elevated adrenal androgens at baseline and achieved robust reductions in disease driving hormones, with many patients in the study achieving normal levels of these hormones.

Currently Enrolling

Spruce is currently enrolling patients in two double-blind, placebo-controlled late-stage clinical trials in adult patients with classic CAH.

Spruce also plans to initiate a Phase 2 trial in pediatric classic CAH patients.

CAHMELIA 203 / 204

CAHMELIA 203

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia