Denovo Biopharma has introduced DB104 (liafensine), a pioneering treatment for treatment-resistant depression (TRD).
Liafensine operates as a groundbreaking triple reuptake inhibitor, aiming at serotonin, norepinephrine, and dopamine transporters.
In the United States alone, more than 23 million individuals suffer from major depressive disorder (MDD). Approximately 30 percent of individuals do not experience benefits from existing antidepressants and develop treatment-resistant depression (TRD).
TRD remains a significant unmet medical need due to the scarcity of approved pharmacological agents, leading to persistently poor outcomes.
The ENLIGHTEN trial, which included 197 patients with TRD, demonstrated notable advancements. Those who tested positive for the DGM4 biomarker and received liafensine exhibited substantial improvements over six weeks compared to those receiving a placebo.
Liafensine resulted in a 4.4-point enhancement on the depression scale compared to placebo (p = 0.0056). Additionally, secondary measures such as symptom severity and disability scale indicated approximately a 36 percent improvement with liafensine over placebo.
Overall, liafensine demonstrated excellent tolerability and maintained a favourable safety profile, consistent with previous trials involving more than 2,200 participants. This marks a significant stride in precision medicine for CNS disorders, marking the inaugural instance where a genetic biomarker has been leveraged to identify responders among patients with treatment-resistant depression (TRD).
