Denovo Biopharma’s Phase 2b ENLIGHTEN trial has demonstrated the efficacy and safety of liafensine (DB104) in treating treatment-resistant depression (TRD). Using a novel genetic biomarker, DGM4™, researchers identified patients most likely to respond to liafensine.

Over 23 million Americans suffer from major depressive disorder (MDD), and 30% have TRD, which is notoriously challenging to treat. With few approved medications and poor outcomes, TRD remains a significant medical need.

Liafensine is a triple reuptake inhibitor targeting serotonin, norepinephrine, and dopamine. Denovo’s DGM™ platform identified DGM4™ as a predictor of liafensine’s efficacy in TRD patients.

ENLIGHTEN enrolled 197 patients with TRD, using DGM4™ to guide randomization. DGM4-positive patients treated with liafensine showed significant improvement over placebo after 6 weeks. The primary endpoint, change in Montgomery-Åsberg Depression Rating Scale (MADRS) score, demonstrated a 4.4-point improvement with liafensine (p = 0.0056).

Secondary endpoints were also met, with liafensine showing approximately 36% improvement in Clinical Global Impressions Scale-Severity (CGI-S) and Sheehan Disability Scale (SDS) scores. Additionally, the Clinical Global Impressions Scale-Improvement (CGI-I) was 2.3 for liafensine, a 0.6-point improvement over placebo (p = 0.0026).

Liafensine was well tolerated with an excellent safety profile consistent with previous trials involving over 2,200 subjects.

Matthew Spear, Chief Medical Officer and Chief Development Officer at Denovo, expressed excitement about the results, highlighting the significant improvement in depression symptoms (over 40%) compared to current drugs. He emphasized that the trial represents a breakthrough in precision medicine for CNS diseases, as it is the first time a genetic biomarker has been used to select TRD patients likely to benefit from liafensine.

“The success of ENLIGHTEN is a milestone for Denovo,” said Wen Luo, Chief Executive Officer and Chief Scientific Officer of Denovo, validating their innovative biomarker approach. “We are actively seeking a global partner to expedite the development of liafensine, aiming to provide this treatment to millions of patients in need.”

Source link: http://www.businesswire.com/news/home/20240409550498/en/Denovo-Biopharma-Announces-a-Major-Breakthrough-in-Treatment%E2%80%91Resistant-Depression-with-Precision-Medicine

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.