The vasopressin V1b receptor antagonist, BH-200 is intended to treat major depressive disorder. Credit: Suriyawut Suriya/Shutterstock.

HMNC Brain Health (HMNC) has completed the subject randomisation in its placebo-controlled Phase IIb OLIVE trial of a vasopressin V1b receptor antagonist, BH-200, for major depressive disorder (MDD) treatment.

Designed to assess the safety and efficacy of the therapy in conjunction with a predictive companion diagnostic, the trial includes 338 outpatients and is a part of the company’s Nelivabon programme, aimed at addressing MDD in subjects with HPA-axis dysfunction, a condition affecting roughly 30% of all MDD cases.

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The double-blind trial is claimed to be the ‘largest’ precision psychiatry trial to assess a vasopressin V1b receptor antagonist in the context of depression.

Conducted over an eight-week monotherapy period with a twice-daily dosage of 250mg, the trial aims to offer proof of concept for the therapy, in combination with a V1b polygenic score, to treat MDD.

It will assess the therapy’s efficacy compared to a placebo in subjects with a high value of the V1b polygenic score and compare its effectiveness in subjects with low scores.

It follows a prospective-retrospective approach, in line with US Food and Drug Administration (FDA) guidelines for the co-development of companion diagnostics.

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Initial outcomes of the trial are anticipated in the second quarter of this year.

HMNC Brain Health chief medical officer Dr Hans Eriksson said: “Completing patient randomisation 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.

“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.”

Headquartered in Germany, HMNC is a clinical-stage precision psychiatry biopharma company focused on developing personalised treatments that are driven by predictive companion diagnostics.