Spruce Biosciences And HMNC Brain Health Launch Phase 2 TAMARIND Trial For Major Depressive Disorder, First Patient Dosed

HMNC Brain Health, a global biopharmaceutical company specializing in precision psychiatry, has partnered with Spruce Biosciences, a late-stage biopharmaceutical company focused on neurological disorders, to announce the dosing of the first patient in their Phase 2 clinical trial named TAMARIND (Tildacerfont as Antidepressant Medication and Relief in Depression).

The TAMARIND study is investigating the use of tildacerfont, a corticotropin-releasing factor type 1 (CRF1) receptor antagonist, as a potential treatment for major depressive disorder (MDD). This trial is specifically targeting a biologically distinct subgroup of MDD patients who exhibit dysregulation in the hypothalamic-pituitary-adrenal (HPA) axis, which plays a key role in the body’s response to stress. These patients often experience hyperactive CRF neurotransmission, and tildacerfont is designed to block the CRF1 receptor to help normalize this imbalance.

Hans Eriksson, M.D., Ph.D., MBA, Chief Medical Officer of HMNC. Professor Florian Holsboer, co-founder of HMNC and Head of the Scientific Advisory Board, mentioned, “The initiation of the TAMARIND trial marks an exciting step forward and key milestone in our mission to redefine depression treatment by targeting its biological roots. Decades of research has revealed that excessive release of CRF in the brain is related to the stress response and may cause depression in a substantial portion of patients. This program exemplifies our approach of pairing precision patient selection with novel therapeutics to deliver more personalized solutions to patients.”

Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce, stated, “We believe that HMNC’s proprietary investigational-stage patient selection tool has the potential to enable tildacerfont’s development as a precision therapeutic for personalized medicine in patients with MDD. Tildacerfont may modulate certain hormonal responses to stress, which has the potential to address up to 50% of the MDD patients worldwide using patient selection tool. We are excited to collaborate with HMNC on TAMARIND and advance tildacerfont and the patient selection tool as a potentially novel precision treatment for MDD, an area of significant unmet medical need.”

What sets this trial apart is HMNC’s use of its proprietary investigational-stage patient selection tool. This tool leverages genetic markers to identify MDD patients who are more likely to respond to CRF1 receptor antagonists like tildacerfont. By applying this precision medicine approach, the trial aims to increase the likelihood of success by focusing on patients with a higher probability of therapeutic benefit. Topline results from the TAMARIND trial are expected in the first half of 2026. Additional information about the trial can be found at ISRCTN73588250.