HMNC Brain Health (“HMNC”), a clinical-stage precision psychiatry biopharma company pioneering personalized treatments powered by predictive companion diagnostics, announced  the successful completion of patient randomization for its Phase 2b OLIVE trial. The trial is investigating the efficacy and safety of BH-200, a potent vasopressin V1b receptor antagonist, alongside a predictive companion diagnostic in patients with Major Depressive Disorder (MDD).

The OLIVE trial, comprising 338 outpatients, represents a key milestone in HMNC Brain Health’s flagship Nelivabon program, which aims to address MDD in patients with HPA-axis dysfunction—a subgroup comprising approximately 30% of all MDD cases. By combining BH-200 with advanced genetic diagnostics, HMNC Brain Health seeks to deliver precision treatment options to patients with high unmet needs.The OLIVE trial is the largest precision psychiatry trial conducted worldwide to evaluate a vasopressin V1b receptor antagonist in depression.

“Completing patient randomization for the OLIVE trial underscores HMNC Brain Health’s ability to successfully execute complex, multinational clinical studies in precision psychiatry, as well as embodies our commitment to advancing precision psychiatry by addressing the unique needs of MDD patients with HPA-axis dysfunction,” said Dr. Hans Eriksson, Chief Medical Officer at HMNC Brain Health. “The outcome of the OLIVE trial has the potential to pave the way for a new era in mental health treatment, addressing unmet needs and improving outcomes for patients, families and healthcare systems.”

"This trial translates decades of research on stress-axis dysfunction into actionable, precision-based therapies," said Professor Florian Holsboer, Founder, Head of the Scientific Advisory Board of HMNC Brain Health, and former Director of the Max Planck Institute of Psychiatry. "This trial builds on the foundation of our understanding of the HPA axis and its role in Major Depressive Disorder. By combining cutting-edge genetic diagnostics with targeted treatments like BH-200, we are moving closer to a future where mental health care is truly personalized, offering hope to patients who have long been underserved by traditional approaches."