Study Marks Milestone in Precision Psychiatry for Stress-Axis-Related Depression
MUNICH, Jan. 10, 2025 (GLOBE NEWSWIRE) -- HMNC Brain Health ("HMNC”), a clinical-stage precision psychiatry biopharma company pioneering personalized treatments powered by predictive companion diagnostics, announced today 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."
The OLIVE Trial Design
- Aim: Provide proof of concept for BH-200 combined with a V1b polygenic score as a precision treatment for MDD.
- Objectives:
- Assess the efficacy of BH-200 versus placebo in improving symptoms of MDD in patients with a high value of the V1b polygenic score (V1b-high patients, or patients that carry genetic variants strongly associated with the V1b receptor pathway)
- Compare the efficacy of BH-200 in V1b-high versus patients with a low value of the V1b polygenic score (V1b-low patients, or patients that have fewer or weaker genetic markers linked to the V1b receptor pathway).
- Design: Prospective-retrospective approach, aligning with the FDA's guidance for co-development of companion diagnostics.
- Details: Randomized, double-blind, placebo-controlled trial involving 338 outpatients with MDD, conducted over an 8-week monotherapy period (250mg BID).
About HMNC Brain Health
HMNC Brain Health (HMNC Holding GmbH) is a global precision psychiatry biopharma company headquartered in Munich, Germany, pioneering the development of personalized therapies for Major Depressive Disorder powered by predictive companion diagnostics, leading to higher remission rates. With a presence in both Germany and the U.S., HMNC Brain Health is backed by renowned family offices and strategic healthcare investors. To learn more about HMNC Brain Health and its innovative approach to precision psychiatry, visit www.hmnc-brainhealth.com.
About the Nelivabon Program
The Nelivabon program is focused on developing BH-200, a vasopressin V1b receptor antagonist, to treat Major Depressive Disorder (MDD) related to dysfunction in the human body's stress system, called HPA-axis (Hypothalamus‐pituitary‐adrenal axis). BH-200 targets the elevated activity of vasopressin in the brain caused by repeated stressors, potentially reducing anxiety and depressive symptoms. The neuropeptide vasopressin coordinates hormonal and behavioral adaptation to stress, but repeated stressors can cause an overactive vasopressin system that leads to an increase in anxiety and the development of depressive symptoms. To identify depressed patients with underlying dysfunction of the HPA-axis, who may benefit from treatment with BH-200, the program includes a matching genetic diagnostic test. While the diagnostic test is still in early development, data stemming from this trial is expected to significantly improve its accuracy. BH-200 has shown to be well-tolerated in clinical trials. The program has successfully completed patient randomization in its Phase 2b OLIVE trial, and with top-line results expected soon, it holds the potential to become an efficient treatment option for patients suffering from stress-axis-related MDD.
Media Contact (U.S.):
Anne Donohoe
(732) 620-0033
