HMNC Brain Health, a biopharmaceutical company specializing in precision psychiatry, has announced the completion of patient randomization for its Phase 2b OLIVE trial. This trial is designed to evaluate the efficacy and safety of BH-200, a vasopressin V1b receptor antagonist, in conjunction with a predictive companion diagnostic for patients with Major Depressive Disorder (MDD).
The OLIVE trial, involving 338 outpatients, is a significant component of HMNC Brain Health’s Nelivabon program. This program aims to address MDD in patients with Hypothalamus-Pituitary-Adrenal axis (HPA-axis) dysfunction, a subgroup that constitutes approximately 30% of all MDD cases. By integrating BH-200 with advanced genetic diagnostics, HMNC Brain Health intends to provide targeted treatment options for patients with substantial unmet needs.
Trial Design and Objectives
The OLIVE trial is structured to provide proof of concept for BH-200, used in combination with a V1b polygenic score, as a precision treatment for MDD. The trial's primary objectives include:
- Assessing the efficacy of BH-200 compared to placebo in improving MDD symptoms in patients with a high V1b polygenic score (V1b-high).
- Comparing the efficacy of BH-200 in V1b-high patients versus those with a low V1b polygenic score (V1b-low).
The study employs a prospective-retrospective design, aligning with FDA guidelines for the co-development of companion diagnostics. It is a randomized, double-blind, placebo-controlled trial conducted over an eight-week monotherapy period, with patients receiving a 250mg twice-daily (BID) dosage of BH-200.
Precision Psychiatry Approach
Dr. Hans Eriksson, Chief Medical Officer at HMNC Brain Health, stated, "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." He added that the trial's outcome could "pave the way for a new era in mental health treatment, addressing unmet needs and improving outcomes for patients, families and healthcare systems."
Professor Florian Holsboer, Founder and Head of the Scientific Advisory Board of HMNC Brain Health, emphasized the trial's foundation in decades of research on stress-axis dysfunction. "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," said Holsboer.
About BH-200 and the Nelivabon Program
The Nelivabon program focuses on developing BH-200, a vasopressin V1b receptor antagonist, for treating MDD related to HPA-axis dysfunction. BH-200 aims to reduce anxiety and depressive symptoms by targeting the elevated activity of vasopressin in the brain caused by repeated stressors. The program includes a genetic diagnostic test to identify patients with HPA-axis dysfunction who may benefit from BH-200 treatment. BH-200 has demonstrated good tolerability in previous clinical trials.
Initial results from the OLIVE trial are anticipated in the second quarter of 2025.
