Spruce Biosciences
Developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need
Key Highlights
- CAH Landscape Poised for Major 2024: Outdated congenital adrenal hyperplasia (CAH) treatments leave patients with toxic steroids to manage irregular hormone levels, causing debilitating, long-term side effects. After a 70-year treatment drought, game-changing medicines are (almost) finally here, with Spruce as one of the companies leading the way.
- Less Steroids, More Control: Current treatments (e.g., steroids) make up for the lack of cortisol, but they’re often given in higher doses than what the body naturally makes. Spruce’s investigational drug, tildacerfont, could be the first new, once-daily oral non-steroidal therapeutic for improving disease control and reducing steroid burden in patients.
- Momentum in Targeting CRF1: With multiple shots on goal investigating breakthrough treatments for CAH, Spruce and Neurocrine are advancing oral corticotropin-releasing factor type 1 (CRF1) receptor antagonists closer to the finish line. These block a receptor involved in controlling hormone and androgen levels. Validated by a growing body of positive data, Spruce’s tildacerfont reduces adrenal androgen production and can potentially impact additional family of androgens.
- 2024: Make or Break year for Spruce
- Topline results from the CAHmelia-204 clinical trial in adult classic CAH patients on supraphysiologic doses of GCs with normal or near normal levels of A4 in the Q3 2024
- Topline interim results from additional dose-ranging in the Phase 2 CAHptain clinical trial in Q3 2024
- End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in the Q1 2025