The Company Shared a Poster Highlighting Groundbreaking Genetic Stratification Data from the Favorable Phase 2b OLIVE Trial Outcomes for BH-200
MUNICH, Germany, Jan. 15, 2026 – HMNC Brain Health (“HMNC”), a clinical-stage precision psychiatry biopharmaceutical company at the forefront of developing personalized treatments powered by predictive genetic selection tools, unveiled new data from its Phase 2b OLIVE trial at the American College of Neuropsychopharmacology (ACNP) Annual Meeting on January 14, 2026, in Atlantis, Bahamas.
Dr. Hans Eriksson, Chief Medical Officer, presented the clinical findings from the OLIVE Phase 2b trial. This study evaluated BH-200 (nelivaptan) in 338 patients diagnosed with Major Depressive Disorder (MDD), utilizing a proprietary genetic selection tool designed to identify responders based on their stress-axis biology.
“These results signify a substantial stride toward precision-guided treatment in the field of depression,” stated Dr. Hans Eriksson, Chief Medical Officer of HMNC Brain Health. “Integrating a genetic selection tool into the clinical development of BH-200 allows us to pinpoint subgroups of patients who are more likely to benefit, moving us beyond a trial-and-error approach to prescribing.”
Favorable Phase 2b Outcomes from the OLIVE Trial (August 2025)
The OLIVE trial (N=338) assessed BH-200, a selective vasopressin V1b receptor antagonist, in individuals with MDD. The study incorporated a proprietary genetic selection tool to categorize patients into three subgroups based on stress-axis dysfunction:
- Full population: Demonstrated a clinically meaningful reduction in depressive symptoms (HAM-D17: -2.98 versus placebo; p = 0.0003)
- Genetically defined subgroup (27% of patients): Exhibited a stronger and earlier response (HAM-D17: -4.47 versus placebo; p = 0.005; MADRS: -5.95; p = 0.002)
- Safety: BH-200 was generally found to be safe and well-tolerated. No serious adverse events were reported within the treatment group.
These results establish first-in-class potential for a hypothalamic-pituitary-adrenal (HPA)-axis modulator (HPAM) in depression and underscore the value of HMNC’s biomarker-guided strategy for identifying biologically defined responder subgroups.
Details Regarding the OLIVE Trial
- Design: Randomized, double-blind, placebo-controlled
- Sites: Eight European countries
- Duration: 8-week monotherapy
- Endpoints: Change in HAM-D17 score; subgroup response based on genetic stratification
- Trial Size: N=338 (modified Intent-to-Treat = 331)
The OLIVE trial represents the largest precision psychiatry study conducted to date evaluating a V1b receptor antagonist for depression.
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Concerning BH-200 and the Nelivabon Program
BH-200 (nelivaptan) is a selective vasopressin V1b receptor antagonist currently undergoing clinical development for MDD patients with hypothalamic-pituitary-adrenal (HPA) axis dysfunction. A proprietary genetic companion diagnostic is being co-developed to identify patients who are biologically most likely to benefit. BH-200 remains an investigational drug and has not received approval from the FDA, EMA, or other regulatory agencies.
About HMNC Brain Health
HMNC Brain Health (HMNC Holding GmbH) is a precision psychiatry biopharmaceutical company dedicated to developing personalized treatments for depression based on predictive genetic selection tools. The company’s pipeline includes three Phase 2 programs targeting Major Depressive Disorder (MDD): Nelivabon, which involves a vasopressin V1b receptor antagonist paired with a proprietary genetic selection tool; Cortibon, focused on a CRHR1 antagonist with a corresponding companion diagnostic; and Ketabon, developing KET01, an extended-release oral ketamine formulation designed for safe, at-home treatment.
Media Inquiries
Anne Donohoe (U.S.)
+1 212-896-1265
hmncbrain@kcsa.com
