HMNC Brain Health (“HMNC”), a global precision psychiatry biopharmaceutical company, in collaboration with Spruce Biosciences, Inc. (OTCQB: SPRB) (“Spruce”), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, announced that the first patient has been dosed in the Phase 2 clinical trial called “Tildacerfont as Antidepressant Medication and Relief in Depression” (TAMARIND).

TAMARIND is evaluating tildacerfont, a corticotropin-releasing factor type 1 (CRF₁) receptor antagonist, as a potential treatment for major depressive disorder (MDD) in patients selected using HMNC’s proprietary investigational-stage patient selection tool. TAMARIND targets a biologically distinct subtype of MDD patients tied to hypothalamic-pituitary-adrenal (HPA) axis dysregulation. Tildacerfont has the potential to address hyperactive brain corticotropin-releasing factor (CRF) neurotransmission and aberrant functioning of the HPA axis in patients with MDD by blocking the CRF₁ receptor. Additionally, by utilizing genetic markers, HMNC’s patient selection tool aims to identify MDD patients who are more likely to respond to CRF₁ receptor antagonism.

“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,” said 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, added: “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.”

“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,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce. “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.”