Spruce Biosciences Inc. (NASDAQ:SPRB) and HMNC Brain Health GmbH have collaborated to develop Spruce’s investigational product candidate, tildacerfont, and HMNC’s companion diagnostic, the proprietary Cortibon Genetic Selection Tool for major depressive disorder (MDD). 

Spruce Biosciences is a late-stage biopharmaceutical company developing its wholly-owned product candidate, tildacerfont, for classic congenital adrenal hyperplasia, polycystic ovary syndrome, and MDD.

“We believe that Cortibon has the potential to enable tildacerfont to be advanced as a precision therapeutic for personalized medicine in patients with MDD,” said Javier Szwarcberg, CEO of Spruce Biosciences. “Hyperactive CRF neurotransmission and CRF1 receptor signal transduction are critical mechanisms for stress pathophysiology that may lead to major depression. Tildacerfont may mediate responses to stress, which has the potential to address up to 50% of MDD patients worldwide using Cortibon.”

“We are excited to collaborate with HMNC and initiate a Phase 2 proof-of-concept study of tildacerfont and Cortibon for the treatment of MDD later this year,” Szwarcberg added.

Under the agreement, HMNC will fund and conduct a Phase 2 proof-of-concept study of tildacerfont in MDD patients, who will be screened using Cortibon.

Spruce has the option to in-license exclusive worldwide rights to Cortibon after the completion of the study, if the results are positive.

If Spruce exercises its option, it will be responsible for the future worldwide development and commercialization of tildacerfont and Cortibon for MDD under a collaboration framework that leverages HMNC’s ongoing expertise in precision psychiatry and companion diagnostics.

Under the license terms, HMNC would be entitled to receive certain milestone payments and tiered royalties on net sales of tildacerfont in MDD. 

Cortibon is HMNC’s proprietary companion diagnostic. By utilizing genetic markers, Cortibon aims to identify MDD patients who are more likely to respond to CRF1 receptor antagonism, thereby enhancing treatment outcomes and reducing the trial-and-error period typical in depression treatment.

Price Action: SPRB shares closed at $0.72 on Monday.