HMNC Brain Health is advancing its multiple depressive disorder (MDD) drug to Phase III trials following promising Phase IIb results, which showed a meaningful reduction in depressive symptoms in a subgroup of patients.
The OLIVE trial (EudraCT-2022-002757-26) evaluated HMNC’s BH-200 (nelivaptan) versus placebo in 338 patients with MDD across eight countries in Europe between May 2023 and April 2025.
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HMNC said that BH-200 led to a clinically meaningful reduction in depressive symptoms after eight weeks of treatment in the full patient population. However, there was a larger and more rapid effect in a patient population, subgroup A, which was identified through HMNC’s proprietary genetic selection tool.
In the main population, symptoms, as measured on the 17-item Hamilton Depression Rating Scale (HAM-D17), reduced by 2.98 points. In the prespecified subgroup, there was a reduction of 4.47 points, each compared to placebo.
The primary endpoint was set for subgroup C in the study, where there was a statistically insignificant reduction of 1.94 points.
The German biotech will now initiate regulatory discussions for Phase III development of BH-200, utilising lessons learnt from the OLIVE trial.
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By GlobalDataHMNC’s MDD drug to advance precision psychiatry
If approved, BH-200 could be the first precision-guided antidepressant in real-world practice. BH-200 is a selective vasopressin V1b receptor antagonist.
This marks a significant advancement in the indication, with HMNC leveraging its proprietary genetic selection tool to identify patients based on biomarkers associated with vasopressin signalling and regulation of the stress-response system, specifically the hypothalamic-pituitary-adrenal (HPA) axis.
The Phase IIb data suggest that lower peripheral vasopressin activity, as was recorded in patients from subgroup A, correlates with stronger central vasopressin activity in relevant brain areas – suggesting that a precision medicine approach does hold merit.
Dr Alan F Schatzberg, Professor of Psychiatry and Behavioural Sciences at Stanford University, noted that this signal from the OLIVE trial is important.
Schatzberg explained: “We’ve long understood the relevance of the HPA-axis in stress-related depression, but this is the first time we’ve seen clear improvement in MDD through vasopressin modulation.
“The clinical utility that is shown via the overall result is also supported by early and robust response in a prior defined subgroup (A), defined along genetic and HPA-axis variation. This could represent a paradigm shift toward more biologically informed treatment decisions in psychiatry.”
HMNC’s drug used to be part of Sanofi’s pipeline; however, the company dropped development of the drug in July 2008 after a trial failed to show benefit in MDD. It has not been publicly reported when HMNC gained rights to the drug, but the first trials were initiated in 2023.
GlobalData estimated that drug sales for MDD in 2019 were approximately $4.73bn across the eight major markets (8MM: the US, France, Germany, Italy, Spain, and the UK, Japan, and Canada), and the market is set to grow to $9.55bn in 2029.
GlobalData is the parent company of Clinical Trials Arena.
