Research indicates a specific group of Major Depressive Disorder patients might respond better to treatment targeting vasopressin V1b receptors.
MUNICH, Oct. 13, 2025 – HMNC Brain Health, a clinical-stage precision psychiatry biopharmaceutical firm specializing in personalized treatments supported by predictive companion diagnostics, today revealed it showcased a retrospective analysis at the International Society for CNS Clinical Trials and Methodology (ISCTM) Autumn Conference in Amsterdam. This analysis illustrated clear bimodal response patterns in patients receiving nelivaptan (BH-200).
The company’s poster, titled “Precision Psychiatry in MDD: Finite Mixture Modeling of Nelivaptan Response Suggests Distinct Responder Classes,” offers fresh data substantiating the biological and methodological basis for HMNC’s current Phase 2b OLIVE trial. This trial incorporates a genetic companion diagnostic to pinpoint patients who are most probable to gain from vasopressin V1b receptor inhibition.
This analysis illustrated a bimodal pattern in the improvement of depressive symptoms, originally noted in Sanofi’s prior Phase 2 study for Major Depressive Disorder (NCT00358631). Patients receiving nelivaptan displayed two separate response groups: one cluster exhibited an average improvement of –17.1 points on the 17-item Hamilton Depression Rating Scale (HAM-D17), whereas another saw a –3.9-point change, in contrast to a –7.1-point change in the placebo cohort after eight weeks of therapy.
These results indicate that a biologically characterized subgroup of individuals suffering from Major Depressive Disorder (MDD) could gain significant advantages from vasopressin V1b receptor antagonism. This aligns with HMNC’s theory that hypothalamic-pituitary-adrenal (HPA) axis dysregulation, also known as stress-axis dysfunction, is a significant contributor to forms of depression resistant to standard treatments.
Dysfunction of the HPA axis has been linked to roughly 30–50% of MDD patients. Nelivaptan works by specifically inhibiting vasopressin V1b receptor signaling, thereby addressing this disrupted stress response system. HMNC’s OLIVE trial is jointly developing BH-200 alongside a proprietary genetic companion diagnostic, with the goal of prospectively identifying and treating this biologically characterized patient group.
“The Sanofi dataset offered an uncommon chance to discern a distinct bimodal response, where one patient cohort experienced significantly greater improvement with nelivaptan,” stated Hans Eriksson, MD, PhD, MBA, Chief Medical Officer of HMNC Brain Health. “This differentiation strengthens our reasoning for combining BH-200 with a genetic companion diagnostic in the OLIVE study. Although the previous trial was unable to include biomarker data, our current efforts directly leverage those findings, enabling us to transition from merely observing to predicting treatment outcomes in depression.”
About HMNC Brain Health
HMNC Brain Health (HMNC Holding GmbH) operates as a precision psychiatry biopharmaceutical entity focused on creating personalized depression treatments using predictive genetic selection methods. The company’s development portfolio encompasses three Phase 2 initiatives for Major Depressive Disorder (MDD): Nelivabon, which is developing a vasopressin V1b receptor antagonist together with a proprietary genetic selection tool; Cortibon, which is developing a CRHR1 antagonist complemented by a corresponding companion diagnostic; and Ketabon, which is developing KET01, a prolonged-release oral ketamine formulation designed for secure, in-home administration.
Media Inquiries:
Anne Donohoe
+1 732-620-0033
Investors:
Maximilian Doebler
Chief Business Officer
HMNC Brain Health
