FDA Grants Fast Track Designation For Biomarker-Guided DB104 (liafensine) in Patients with Treatment-Resistant Depression (TRD)

Fast Track Designation Highlights the Urgent Need for New Treatment Options and Potential Value of Liafensine

SAN DIEGO, Oct. 9, 2024 /PRNewswire/ -- 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.

"This FDA Fast Track designation is an accelerator for liafensine's development," said Xiao-Xiong Lu, PhD, Denovo's Chief Technical  Officer. "We are pleased that FDA has recognized our innovative biomarker approach and will continue to work with the agency to bring this biomarker-based precision medicine to TRD patients."

About Treatment-Resistant Depression

More than 23 million people in the US alone suffer from major depressive disorder (MDD). Over 30% patients with MDD do not benefit from currently available antidepressants and are diagnosed with treatment-resistant depression (TRD). TRD remains a major unmet medical need as there are few approved pharmacological agents for TRD and overall outcomes remain poor.

About DB104 (liafensine)

Liafensine is a first‑in‑class triple reuptake inhibitor targeting transporters for serotonin, norepinephrine, and dopamine. It was licensed from Albany Molecular Research, Inc. (now Curia) and was previously developed by Bristol‑Myers Squibb (BMS: recently obtained FDA approval for Cobenfy™, a first-in-class treatment for schizophrenia), who had conducted two large Phase 2b clinical trials in TRD which failed in non-biomarker-selected patient population. Denovo's unique artificial intelligence (AI) and whole genome sequencing (WGS)-based Denovo Genomic Marker (DGM™) biomarker platform allowed discovery of a novel genetic biomarker, termed DGM4™, with strong correlation of DGM4-positive status with liafensine's efficacy in the BMS studies. The ENLIGHTEN study results prospectively demonstrated  the use of DGM4 as a predictive biomarker for liafensine's efficacy in TRD patients, a first for genetic biomarkers in psychiatry.

About Denovo Biopharma

Denovo Biopharma LLC is a clinical-stage biopharmaceutical company that uses novel biomarker approaches to execute efficient clinical trials in targeted patient subpopulations to increase the probability of success. Denovo has seven late-stage drugs in its pipeline addressing major unmet medical needs in central nervous system diseases and oncology, most of which are first‑in‑class drugs with global rights. Visit www.denovobiopharma.com for additional information.

Contact

Michael F. Haller, PhD
Chief Business Officer and Head of US Finance
Denovo Biopharma LLC
[email protected]

SOURCE Denovo Biopharma LLC