NEW YORK – HMNC Brain Health has enrolled the first patient in a Phase II study assessing the efficacy of its precision depression drug, the German biopharmaceutical company said Tuesday.
Investigators in eight European countries plan to enroll more than 300 patients with major depressive disorder in the Olive trial, a randomized, placebo-controlled study testing Munich, Germany-based HMNC's BH-200, a vasopressin V1b receptor antagonist.
HMNC is gauging BH-200's efficacy treating depression in patients with underlying hypothalamus‐pituitary‐adrenal axis (HPA-axis) dysfunction, which can be caused by repeated stressors and possibly lead to anxiety and depressive symptoms. The drug targets elevated activity of vasopressin, a neuropeptide found in the brain that coordinates hormonal and behavioral responses to stress.
Although the Olive study will enroll patients with depression regardless of biomarker status, HMNC does plan to home in on best responders to BH-200. In a post hoc analysis, the Olive study investigators will also evaluate a V1b polygenic score that the company plans to develop into a companion diagnostic.
Data from the Olive trial is expected to improve accuracy of the polygenic score, which is still in early development. HMNC estimates approximately 30 percent of the population will have a high V1b polygenic score and respond best to BH-200.
The firm expects to have an initial data readout from the Olive trial in the second half of 2024.