Denovo Biopharma LLC to Present Positive Phase 2b ENLIGHTEN Trial Data for DGM4 Biomarker-Guided DB104 (liafensine) Treatment for Treatment ‑Resistant Depression at the ASCP 2024 Annual Meeting

SAN DIEGO, May 28, 2024 /PRNewswire/ -- Denovo Biopharma LLC (Denovo), a pioneer in applying precision medicine to the development of innovative drugs, today announced that positive results for its biomarker-‑guided Phase 2b clinical trial (ENLIGHTEN) designed to assess the efficacy and safety of DB104 (liafensine) in patients with treatment-resistant depression (TRD) will be presented at two sessions at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami, FL (https://ascpp.org/ascp-meetings/ascp-annual-meeting/):

• The oral presentation will be discussed in a session entitled "Use of Biomarkers to Identify Treatments for Psychiatric Patients: The Right Medicine for the Right Patient at the Right Time" will be chaired by Larry Alphs, MD, PhD on Thursday, May 30, from 4:15 PM to 6:15 PM Eastern Time in Salon 2.
  
  
• Poster W38, entitled "Use of a Novel Pharmacogenomic Biomarker to Enrich Responders for Liafensine in Treatment-Resistant Depression Patients in a Phase 2b Clinical Study" will be presented by Matt Spear, MD on Wednesday, May 29, at 11:15 AM Eastern Time in Salon 4.

Matthew A. Spear, MD, Chief Medical Officer of Denovo Biopharma said, "We are pleased to present detailed positive data from our ENLIGHTEN late-stage trial in TRD for the first time.  The trial met its primary and secondary endpoints and demonstrated the utility of Denovo's unique genetic biomarker discovery platform.  DGM4 guided enrollment of patients, thus indicating where liafensine may provide physicians and patients badly-needed therapies for TRD, which has a high unmet need.  Additionally, to my knowledge this is the first time that a genetic biomarker has been used to identify and select the right patients for treatment in a psychiatric disease.  This could enable easy identification of the appropriate treatment for patients via a simple blood draw or buccal swab in a clinical practice."

About the ENLIGHTEN Phase 2b Clinical Study

The ENLIGHTEN study, a DGM4 biomarker-‑guided, randomized, double ‑blind, placebo ‑controlled global Phase 2b trial designed to validate the biomarker hypothesis, enrolled 197 patients with TRD. DGM4‑positive TRD patients who received liafensine demonstrated highly significant improvements over the 6 ‑week treatment period compared to those who received placebo. The primary endpoint was met: the change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline for liafensine demonstrated a 4.4‑point improvement over placebo (p = 0.0056). All secondary endpoints were also met: changes in both the Clinical Global Impressions Scale‑Severity (CGI‑S) and the Sheehan Disability Scale (SDS) change from baseline for liafensine showed an approximately 36% improvement over placebo; 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 and demonstrated an excellent safety profile consistent with previous clinical trials which included more than 2,200 subjects.

For more information on ENLIGHTEN, visit https://clinicaltrials.gov/ct2/show/NCT05113771.

About Treatment-Resistant Depression (TRD)

More than 23 million people in the U.S. alone suffer from major depressive disorder (MDD). Over 30% do not benefit from currently available antidepressants and are diagnosed with TRD. TRD remains a highly unmet medical need indication 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, who had conducted two large Phase 2b clinical trials in TRD, in a total of more than 2,200 subjects.  Its unique artificial intelligence (AI) and whole genome sequencing (WGS) based Denovo Genomic Marker (DGM™) biomarker platform allowed Denovo to discover a novel genetic biomarker, termed DGM4™. The ENLIGHTEN study results supports the ability of the DGM4 biomarker to predict liafensine's efficacy in TRD patients.

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 eight late-stage drugs in its pipeline addressing major unmet medical needs in oncology and central nervous system diseases, 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