Pharma Focus Asia

Spruce Biosciences and HMNC Brain Health Team Up to Develop Innovative Treatment for Major Depressive Disorder (MDD)

Wednesday, June 05, 2024

Spruce Biosciences, Inc. (Nasdaq: SPRB) (“Spruce”), a biopharmaceutical company specializing in advanced therapies for endocrine and neurological disorders, and HMNC Brain Health GmbH (“HMNC”), a global leader in precision psychiatry, have announced a strategic partnership. This collaboration will integrate Spruce’s investigational drug, tildacerfont, a next-generation CRF1 receptor antagonist, with HMNC’s companion diagnostic tool, Cortibon, to treat Major Depressive Disorder (MDD).

"Hyperactive CRF neurotransmission and CRF1 receptor signaling are critical in stress-related pathophysiology that can result in major depression," said Dr. Javier Szwarcberg, CEO of Spruce Biosciences. "We believe Cortibon can enable tildacerfont to be developed as a precision therapy for personalized medicine in MDD patients. Partnering with HMNC allows us to initiate a Phase 2 proof-of-concept study later this year."

HMNC, emphasized the difficulty in treating MDD due to patient diversity, which often results in inadequate responses to current treatments. "Our collaboration with Spruce is a significant step in precision psychiatry. By combining Cortibon with tildacerfont, we aim to enhance treatment efficacy and reduce the trial-and-error cycle that patients currently endure," said Dr. Doebler.

According to the agreement, HMNC will fund and conduct the Phase 2 proof-of-concept study of tildacerfont in MDD patients, who will be screened using Cortibon. Spruce has the option to obtain exclusive worldwide rights to Cortibon after the study, based on positive results. If Spruce exercises this option, they will manage global development and commercialization of both tildacerfont and Cortibon for MDD, with HMNC providing ongoing expertise in precision psychiatry. HMNC will receive milestone payments and tiered royalties on net sales under the license agreement.

Tildacerfont is a potent, selective, non-steroidal, oral CRF1 receptor antagonist. The CRF1 receptor, which responds to corticotropin-releasing factor (CRF) secreted by the hypothalamus, is primarily located in the brain and pituitary gland and regulates the hypothalamic–pituitary-adrenal (HPA) axis. By blocking the CRF1 receptor, tildacerfont may mitigate hyperactive CRF neurotransmission and dysfunctional HPA axis activity in MDD patients. Completed studies have reported no serious adverse events related to tildacerfont treatment.

Cortibon, HMNC’s proprietary diagnostic tool, uses genetic markers to identify MDD patients who are more likely to respond to CRF1 receptor antagonists, thereby improving treatment outcomes and reducing the trial-and-error process. Traditional MDD treatments often result in prolonged onset times and insufficient response rates, but Cortibon aims to enhance treatment efficacy and reduce costs and time, potentially revolutionizing MDD treatment.



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