ANK3 as a Novel Genetic Biomarker for Liafensine in Treatment-Resistant Depression

Does the newly discovered ANK3 pharmacogenomic biomarker predict the response of patients with treatment-resistant depression (TRD) to liafensine, a triple reuptake inhibitor, despite failure in a non–biomarker-selected TRD patient population in prior phase 2b trials?In this randomized clinical trial including 189 ANK3-positive patients with TRD, liafensine demonstrated a 4.4-point Montgomery-Åsberg Depression Rating Scale improvement over placebo, a clinically meaningful and statistically significant difference.This represents a first successful genetic biomarker-guided clinical trial in psychiatry, advancing a new treatment for TRD and providing a new path for developing precision medicines in the field.

Corresponding Authors: Matthew A. Spear, MD, Denovo Biopharma LLC, 6331 Nancy Ridge Dr, San Diego, CA 92121 (mspear@denovobiopharma.com); Gang Wang, MD, Beijing Anding Hospital, Capital Medical University, 5 Ankang Ln, Dewai Ave, Xicheng District, Beijing 100088, China (gangwangdoc@ccmu.edu.cn).

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