Denovo Biopharma has secured approval from the US Food and Drug Administration (FDA) to begin a Phase IIb clinical trial of DB104 (liafensine) in individuals with treatment-resistant depression (TRD).

The trial will analyse the safety and efficacy of liafensine in TRD patients. Denovo noted that it will be the third potentially pivotal international trial to be carried out by the company and the first-ever genetic biomarker-guided trial for diseases of the central nervous system (CNS).

Denovo Biopharma chief technical officer Xiao-Xiong Lu said: “CNS diseases are notoriously difficult to treat, and lack of precision medicines may contribute to the modest success in developing innovative drugs in this area.

“Denovo used its unique biomarker platform to identify a novel predictive biomarker named Denovo Genomic Marker 4 (DGM4), which is highly associated with clinical response to liafensine in patients with TRD.”

Developed initially by AMRI, liafensine was licenced to Bristol-Myers Squibb (BMS). 

Later, Denovo gained worldwide rights to the drug, which comprise research and development, manufacturing and supply. 

In various Phase II trials carried out by BMS, liafensine demonstrated increased tolerance in TRD patients. 

Nearly one-third of the major depressive disorder patients do not respond well to a minimum of two distinct antidepressants of sufficient dose and time in the present depressive episode and are classified as having TRD.

Currently, Denovo’s pipeline includes eight late clinical-stage drugs intended to address key unmet medical needs in oncology and CNS diseases.

The company’s trial for its lead asset DB102 (enzastaurin) has concluded enrolment of subjects with diffuse large B-cell lymphoma in a Phase III trial in the US and China while enrolment is underway in a Phase III glioblastoma trial.