MUNICH, Oct. 13, 2025 (GLOBE NEWSWIRE) -- HMNC Brain Health, a clinical-stage precision psychiatry biopharmaceutical company developing personalized treatments powered by predictive companion diagnostics, today announced it presented a retrospective analysis demonstrating distinct bimodal response distributions in patients treated with nelivaptan (BH-200) at the International Society for CNS Clinical Trials and Methodology (ISCTM) Autumn Conference in Amsterdam.
The Company’s poster, titled “Precision Psychiatry in MDD: Finite Mixture Modeling of Nelivaptan Response Suggests Distinct Responder Classes,” presents new findings that support the biological and methodological rationale for HMNC’s ongoing Phase 2b OLIVE trial. That trial integrates a genetic companion diagnostic to identify patients most likely to benefit from vasopressin V1b receptor inhibition.
The analysis visualizes a bimodal distribution in improvement of depressive symptoms observed in Sanofi’s earlier Phase 2 study in Major Depressive Disorder (NCT00358631). Patients treated with nelivaptan exhibited two distinct clusters of response: one subgroup showed a mean change of –17.1 points on the 17-item Hamilton Depression Rating Scale (HAM-D17), while another showed –3.9 points compared with a –7.1-point change in the placebo group after eight weeks of treatment.
These findings suggest that a biologically defined subset of individuals with Major Depressive Disorder (MDD) may derive substantial benefit from vasopressin V1b receptor antagonism. This is consistent with HMNC’s hypothesis that hypothalamic-pituitary-adrenal (HPA) axis dysregulation, also referred to as stress-axis dysfunction, plays a key role in treatment-resistant forms of depression.
Perturbation of the HPA axis has been implicated in approximately 30–50% of patients with MDD. By selectively inhibiting vasopressin V1b receptor signaling, nelivaptan targets this disturbed stress response system. HMNC’s OLIVE trial co-develops BH-200 with a proprietary genetic companion diagnostic, aiming to prospectively identify and treat this biologically defined subgroup.
“The Sanofi dataset provided a rare opportunity to observe a clear bimodal response pattern, where one group of patients experienced a much greater improvement on nelivaptan,” said Hans Eriksson, MD, PhD, MBA, Chief Medical Officer of HMNC Brain Health. “That separation reinforces our rationale for pairing BH-200 with a genetic companion diagnostic in the OLIVE study. While the earlier trial could not incorporate biomarker data, our work now builds directly on those findings, helping us move from observation to prediction in how we treat depression.”
About HMNC Brain Health
HMNC Brain Health (HMNC Holding GmbH) is a precision psychiatry biopharmaceutical company developing personalized treatments for depression based on predictive genetic selection tools. The company’s pipeline includes three Phase 2 programs in Major Depressive Disorder (MDD): Nelivabon, developing a vasopressin V1b receptor antagonist paired with a proprietary genetic selection tool; Cortibon, developing a CRHR1 antagonist with a matching companion diagnostic; and Ketabon, developing KET01, a prolonged-release oral ketamine formulation designed for safe, at-home treatment.
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Anne Donohoe
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Investors:
Maximilian Doebler
Chief Business Officer
HMNC Brain Health
maximilian.doebler@hmnc-brainhealth.com
