HMNC Brain Health has completed patient randomization for its Phase 2b OLIVE trial, investigating the efficacy and safety of BH-200, a vasopressin V1b receptor antagonist, combined with a predictive companion diagnostic for Major Depressive Disorder (MDD). The trial focuses on patients with HPA-axis dysfunction, representing roughly 30% of all MDD cases, and is the largest of its kind globally. This achievement signifies a major step in HMNC’s Nelivabon program, aimed at delivering personalized MDD treatments.
This development holds substantial promise for advancing the treatment of depression. The trial specifically targets a significant subset of MDD patients whose condition is rooted in HPA-axis dysfunction, a biological mechanism often resistant to conventional treatments. Successful results could offer a new therapeutic avenue for these patients, potentially leading to improved remission rates and quality of life. This precision medicine approach could also drive more efficient resource allocation in healthcare by targeting treatments to those most likely to benefit.
The OLIVE trial, encompassing 338 outpatients, uses a randomized, double-blind, placebo-controlled design. It evaluates the efficacy of BH-200 compared to placebo over an eight-week period, differentiating between patients with high and low values of a V1b polygenic score. This prospective-retrospective approach aligns with FDA guidance for companion diagnostic co-development. Initial trial results are anticipated in Q2 2025.
Positive results from the OLIVE trial could mark a turning point in MDD treatment, establishing BH-200 as a first-in-class therapy for patients with stress-axis-related depression. This would validate HMNC’s precision psychiatry platform and could pave the way for broader application of this approach in mental health. Furthermore, positive data will refine the companion diagnostic, increasing its predictive accuracy and further personalizing treatment strategies. The trial’s outcome is poised to significantly impact the landscape of mental healthcare and potentially redefine the standard of care for this prevalent and debilitating condition.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
