Spruce Biosciences and HMNC Brain Health Collaborate on MDD Treatment Development

Spruce Biosciences, Inc., a late-stage biopharmaceutical company, and HMNC Brain Health GmbH, a precision psychiatry biopharma firm, have announced a strategic collaboration. This partnership aims to develop Spruce’s investigational product candidate, tildacerfont, in conjunction with HMNC’s companion diagnostic tool, Cortibon, for the treatment of major depressive disorder (MDD).

Tildacerfont is a second-generation CRF1 receptor antagonist developed by Spruce Biosciences. It targets hyperactive corticotropin-releasing factor (CRF) neurotransmission and CRF1 receptor signal transduction, key mechanisms involved in stress pathophysiology that can lead to major depression. By potentially mediating stress responses, tildacerfont could address the needs of up to 50% of MDD patients globally when used with Cortibon.

Cortibon, developed by HMNC Brain Health, is a proprietary genetic selection tool designed to identify MDD patients likely to respond to CRF1 receptor antagonism. This approach could significantly improve treatment outcomes and reduce the trial-and-error period commonly associated with traditional depression treatments. The collaboration between Spruce and HMNC aims to leverage these strengths to advance precision psychiatry and deliver personalized medicine to MDD patients.

Javier Szwarcberg, M.D., M.P.H., CEO of Spruce Biosciences, expressed optimism about the collaboration, highlighting the potential of Cortibon to enhance the precision of tildacerfont as a therapeutic for MDD. Dr. Maximilian Doebler, Chief Business Officer of HMNC, emphasized the significant step forward in treating MDD patients, who often face a costly and prolonged trial-and-error cycle with traditional therapies. By using genetic markers to predict responses to psychiatric medications, the collaboration aims to enhance treatment efficacy and reduce overall costs.

Under the terms of the agreement, HMNC will fund and conduct a Phase 2 proof-of-concept study of tildacerfont in MDD patients, screened using Cortibon. If the study results are positive, Spruce has the option to acquire exclusive worldwide rights to Cortibon. Should Spruce exercise this option, it will assume responsibility for the global development and commercialization of both tildacerfont and Cortibon for MDD treatment. HMNC will receive milestone payments and tiered royalties on net sales under this arrangement.

Tildacerfont is a non-steroidal, oral antagonist of the CRF1 receptor, primarily regulating the hypothalamic-pituitary-adrenal (HPA) axis by blocking CRF1 receptors in the brain and pituitary gland. This mechanism has the potential to address hyperactive brain CRF neurotransmission and HPA axis dysfunction in MDD patients. Previous studies have shown that tildacerfont has not been associated with drug-related serious adverse events.

Cortibon aims to revolutionize MDD treatment by utilizing genetic markers to predict patient responses to CRF1 receptor antagonism. This could potentially shorten the time to effective treatment and improve response rates, addressing the limitations of traditional treatments that often involve long onset times and inadequate outcomes.

Spruce Biosciences focuses on developing novel therapies for endocrine and neurological disorders with significant unmet medical needs. The company is advancing tildacerfont for the treatment of conditions like congenital adrenal hyperplasia (CAH), polycystic ovary syndrome (PCOS), and MDD.

HMNC Brain Health is pioneering precision psychiatry by developing personalized therapies powered by predictive companion diagnostics. The company is advancing multiple programs targeting major depressive disorder and treatment-resistant depression.

This collaboration represents a promising step towards innovative and personalized treatment options for patients suffering from major depressive disorder.