HMNC Brain Health and Spruce Biosciences Announce First Patient Dosed in Phase 2 TAMARIND Trial For Major Depressive Disorder
Study Initiation Marks Key Milestone in Advancing Precision Psychiatry Treatment for Major Depressive Disorder
Topline Results Anticipated in the First Half of 2026
MUNICH, Germany and SOUTH SAN FRANCISCO, Calif., July 22, 2025 (GLOBE NEWSWIRE) -- 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."
Topline results from TAMARIND are anticipated in the first half of 2026. More information regarding the clinical trial can be found at ISRCTN73588250.
About TAMARIND
TAMARIND is a randomized, double-blind, placebo-controlled, Phase 2 proof-of-concept clinical trial evaluating the safety, efficacy, and tolerability of tildacerfont in 88 adults with MDD, who are selected utilizing HMNC's proprietary investigational-stage patient selection tool, over an eight-week treatment period followed by a four-week follow-up period. The primary endpoint is the change in depression total scores from baseline using the Hamilton Depression Rating Scale. Key secondary endpoint is the change in functional impairment as measured using the Sheehan Disability Scale. Other measures assess response, remission, and overall quality of life. The study is being conducted in collaboration with Spruce across eight sites in the United Kingdom.
About Tildacerfont
Tildacerfont is a potent and highly selective, non-steroidal, oral antagonist of the corticotropin-releasing factor type 1 (CRF1) receptor, which is the receptor for corticotropin-releasing factor (CRF), a hormone that is secreted by the hypothalamus. The CRF1 receptor is abundantly expressed in the brain and pituitary gland, where it is a key regulator of the hypothalamic–pituitary-adrenal (HPA) axis. By blocking the CRF1 receptor, tildacerfont has the potential to address hyperactive brain CRF neurotransmission and aberrant functioning of the HPA axis in patients with MDD. No drug-related serious adverse events have been reported related to tildacerfont treatment in completed studies.
About HMNC's Proprietary Investigational-Stage Patient Selection Tool
By utilizing genetic markers, the investigational-stage patient selection tool aims to identify MDD patients who are more likely to respond to CRF1 receptor antagonism. This may dramatically change the treatment paradigm in depression, going from a trial-and-error approach to selection of a specific intervention based on the individual patient's biology, thereby improving treatment efficacy and reducing both costs and time.
About HMNC Brain Health
HMNC is a global precision psychiatry biopharmaceutical company pioneering the development of personalized therapies for MDD powered by predictive selection tool. HMNC aims to transform mental health treatment by targeting the biological drivers of psychiatric disorders. Learn more at www.hmnc-brainhealth.com
About Spruce Biosciences
Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need. To learn more, visit www.sprucebio.com and follow us on X, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the design, results, conduct, progress and timing of the Phase 2 TAMARIND trial; the potential for HMNC's proprietary investigational-stage patient selection tool to enable tildacerfont's development as a precision therapeutic for MDD and other disorders; the potential to address up to 50% of the MDD patients worldwide using HMNC's proprietary investigational-stage patient selection tool; tildacerfont's potential to mediate hormonal stress responses; Spruce's product candidate, strategy and regulatory matters; and the anticipated timing of topline results from the TAMARIND trial. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "aims," "anticipate," "may," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Spruce's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Spruce's business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Spruce's filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Spruce undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
HMNC Media Contact
Anne Donohoe
(732) 620-0033
[email protected]
Spruce Media
Katie Beach Oltsik
Inizio Evoke Comms
(937) 232-4889
[email protected]
[email protected]
HMNC Investors
KCSA Strategic Communications
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Spruce Investors
Samir Gharib
President and CFO
Spruce Biosciences, Inc.
[email protected]
