Denovo Biopharma LLC, a pioneer in applying precision medicine to development of innovative drugs, today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for DB104 (liafensine) being developed for treating patients with treatment-resistant depression (TRD). Fast Track designation may potentially expedite the review of a drug that is intended for the treatment of a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need for such a disease or condition.
TRD is the most difficult depression to treat and TRD patients have limited treatment options that are often associated with significant treatment-related toxicities. Furthermore, clinicians have challenges identifying the appropriate therapies that most likely benefit these patients. Denovo’s discovery of a novel pharmacogenomic biomarker, DGM4™, presents a new era for liafensine, a first-in-class triple reuptake inhibitor. The positive results from the biomarker-guided Phase 2b ENLIGHTEN clinical trial, which met all endpoints including the primary endpoint of the Montgomery-Åsberg Depression Rating Scale (MADRS) total score change from baseline at 6 weeks vs. control (p=0.0056), represent a major advance in TRD as well as the application of precision medicine to psychiatric diseases. Liafensine’s safety profile was also favorable, without reports of side effects common for approved TRD drugs, such as dissociation, respiratory depression, movement disorders, and metabolic dysfunction with morbid weight gain.
